Ignite Creation Date:
2024-05-06 @ 12:46 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03846284
Status:
UNKNOWN
Last Update Posted:
2019-02-19
First Post:
2019-02-10
Brief Title:
Caudal Versus Intravenous Magnesium Sulfate on Emergence Agitation After Sevoflurane In Children
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Caudal Versus Intravenous Magnesium Sulfate In The Prevention OF Emergence Agitation After Sevoflurane Anesthesia For Lower Abdominal Surgeries In Children
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sevoflurane is the agent of choice for induction and maintenance of day care anesthesia in children and has a wide acceptance among pediatric anesthesiologists
Emergence agitation EA is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery eg sevoflurane Magnesium sulfate is a non anesthetic N-methyl-D-aspartate receptor antagonist Regional anesthetic techniques have major two benefits which are lowering anesthetic requirements intraoperatively and providing adequate postoperative pain relief
Magnesium sulfate is an adjuvant that alters the perception and duration of pain by serving as an antagonist of N-methyl-D-aspartate glutamate receptors Caudal injection of bupivacaine with magnesium sulfate in pediatric patients after inguinoscrotal operations provided adequate postoperative analgesia without producing many side effects Caudal block with local anesthetic with or without adjuvants may prevent emergence agitation with effective postoperative pain management
So the aim of this study is to compare the efficacy of caudal versus intravenous magnesium sulfate infusions in controlling emergence agitations after inhalational sevoflurane anesthesia in children who will undergo lower abdominal surgeries
Participants and methods
All participants will receive caudal block with bupivacaine 025 1mgkg dialed in 10 cm saline
The participants will be divided to 3 groups
1 Bupivacaine group B group group 1 N 31 -
2 Magnesium sulfate caudal group MC group group 2 N 31 -
3 Magnesium sulfate IV group MV group group 3 N 31 -
Postoperative assessment in the PACU-
The oxygen saturation SO2 heart rate HR and mean arterial pressure MAP are monitored by the observer blinded to group allocation on admission and 10 mins till discharge 0 10 20 30 40 50 60mints time of discharge from the PACU
Emergence agitations Pediatric anesthesia emergency delirium scale PAED The presence of Emergence agitation and its severity will be measured using PAED
The presence of Pain and its severity will be measured using FLACC scale
Time of first postoperative administration of fentanyl in mints
Modified Aldrete score - The discharge from the PACU will be measured using Modified Aldrete score
Emergence agitation EA is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery eg sevoflurane Magnesium sulfate is a non anesthetic N-methyl-D-aspartate receptor antagonist Regional anesthetic techniques have major two benefits which are lowering anesthetic requirements intraoperatively and providing adequate postoperative pain relief
Magnesium sulfate is an adjuvant that alters the perception and duration of pain by serving as an antagonist of N-methyl-D-aspartate glutamate receptors Caudal injection of bupivacaine with magnesium sulfate in pediatric patients after inguinoscrotal operations provided adequate postoperative analgesia without producing many side effects Caudal block with local anesthetic with or without adjuvants may prevent emergence agitation with effective postoperative pain management
So the aim of this study is to compare the efficacy of caudal versus intravenous magnesium sulfate infusions in controlling emergence agitations after inhalational sevoflurane anesthesia in children who will undergo lower abdominal surgeries
Participants and methods
All participants will receive caudal block with bupivacaine 025 1mgkg dialed in 10 cm saline
The participants will be divided to 3 groups
1 Bupivacaine group B group group 1 N 31 -
2 Magnesium sulfate caudal group MC group group 2 N 31 -
3 Magnesium sulfate IV group MV group group 3 N 31 -
Postoperative assessment in the PACU-
The oxygen saturation SO2 heart rate HR and mean arterial pressure MAP are monitored by the observer blinded to group allocation on admission and 10 mins till discharge 0 10 20 30 40 50 60mints time of discharge from the PACU
Emergence agitations Pediatric anesthesia emergency delirium scale PAED The presence of Emergence agitation and its severity will be measured using PAED
The presence of Pain and its severity will be measured using FLACC scale
Time of first postoperative administration of fentanyl in mints
Modified Aldrete score - The discharge from the PACU will be measured using Modified Aldrete score
Detailed Description:
Participants and methods All participants will receive caudal block with bupivacaine 025 1mgkg diluted in 10 cm saline
The participants will be divided to 3 groups
1 Bupivacaine group B group group 1 N 31 - The participants will receive caudal block with bupivacaine 025 1mgkg diluted in 10 cm saline
IV injection of 10 cm saline over 10 mins then followed by IV infusion 50 cm saline with rate 10-20 mlh according to child weight
2 Magnesium sulfate caudal group MC group group 2 N 31 - The participants will receive caudal block with bupivacaine 025 1mgkg plus Magnesium sulfate 50 mg diluted in 10 cm saline
IV injection of 10 cm saline over 10 mins then followed by IV infusion of 50 cm saline with rate 10-20 mlh according to child weight
3 Magnesium sulfate IV group MV group group 3 N 31 - The participants will receive caudal block with bupivacaine 025 1mgkg diluted in 10 cm saline
IV injection of Magnesium sulfate 30mgkg diluted in 10 cm saline over 10 mins then followed by IV infusion one ampule of Magnesium sulfate 500mg diluted in 50 cm saline with rate 10 mgkgh
Standard monitoring is used during anesthesia and surgery include - electrocardiography non-invasive arterial pressure arterial oxygen saturation using pulse oximeter and end-tidal concentrations are measured using capnography
An intravenous line is secured before induction of anesthesia all participants will receive a standardized rapid sequence induction of anesthesia and oxygen administration for 3 minutes Anesthesia is induced with Inhalation of 8 sevoflurane without use of muscle relaxant cricoid pressure is applied and the trachea intubated with a suitable-size endotracheal tube Maintained end-tidal sevoflurane concentration will be between 25-35 and will be titrated The participants will breath spontaneously during surgery and tidal volume will be adjusted to maintain normocarbia IV injection of 02 mgkg dexamethasone after induction as a prophylaxis of post-operative nausea and vomiting of Mg sulfate Caudal block will be performed to participants before surgical incision with 1 of 2 investigators using the following technique - The Participants are placed in left lateral position after induction of general anesthesia The back of the participant including the sacral hiatus are carefully sterilized with an antiseptic solution and sterile drapes will be placed around the injection site The technique will be done by introducing a 23-gauge hypodermic needle perpendicular to the sacrococcygeal membrane with the bevel in the direction of the long fibers of the membrane The needle will be inserted until there is release of impedance as it pierced the sacrococcygeal membrane Then it is directed upwards so that it make an angle of 20-30 with the skin about 2 mm so that the whole bevel will be inside the sacral canal The injection will be made over a period of about 60 s and then a small elastoplast dressing is placed over the injection site and the participant will be placed supine Intraoperative analgesic supplement will not be given
Caudal block will be failed if HR or MAP increased 10 more than the previous basal value of beginning of surgeryparticipants will be fasting 4-6 hours for solid foods and 2 hours for clear fluids Balanced fluid therapy containing Na Cl glucose K and Ca will be infused according to body weight as follows 1st 10 kg 4 mlkghour 2nd 10 kg 2 mlkghour and 1 mlhour for every 1 kg
Then anesthetic gas discontinued and replaced O2 100 At the end of the operation the trachea is extubated The participants will be transferred to the postanesthesia care unit PACU
Intraoperative assessment-
Heart rate HR and mean arterial blood pressure MAP oxygen saturation SO2 are recorded basal before operation and every 10 mins until the end of surgery
minimal alveolar concentration MAC of sevoflurane is recorded every 10 mins
The occurrence of intraoperative hypotension defined as systolic arterial pressure 70 plus twice the age in years and associated with altered peripheral perfusion requiring a fluid bolus
The occurrence of intraoperative bradycardia defined as heart rate below 60 beats min for ages above 1 years requiring atropine
Duration of anesthesia it is the time from start of inhalation induction by sevoflurane till tracheal extubation in mins
Extubation time it is the time from termination of sevoflurane to tracheal extubation in mins
Emergence time it is the time from the end of surgery till the opening of patients eyes in mins
Interaction time it is interval between stopping sevoflurane and verbal or physical response in mins All are noted
Postoperative assessment in the PACU-
The oxygen saturation SO2 heart rate HR and mean arterial pressure MAP are monitored by the observer blinded to group allocation on admission and 10 mins till discharge 0 10 20 30 40 50 60mints time of discharge from the PACU
Emergence agitations Pediatric anesthesia emergency delirium scale PAED- The presence of Emergence agitation and its severity will be measured using PAED
Item 1 The participant makes eye contact with care giver 2 The childs actions are purposeful 3 The child is aware of hisher surroundings 4 The child is restless 5 The child is inconsolable - Items 1 2 and 3 are scored 4 not at all 3 just a little 2 quite a bit 1 very much 0 extremely
- Items 4 and 5 are scored 0 not at all 1 just a little 2 quite a bit 3 very much 4 extremely
It will be monitored on admission and every 10 mins till discharge from the PACU 0 10 20 30 40 50 60 mins time of discharge
PAED score 10 will be managed by intravenous doses of fentanyl 1micgkg repeated after 10 min if the child is still agitated with a maximum total dose of 2 micgkg PAED score 10 will be considered to be a diagnostic endpoint for the development of agitation
Pain score FLACC scale -
The presence of Pain and its severity will be measured using FLACC scale
CATEGORIES SCORING
0 1 2 Face
No particular expression or smile Occasional grimace or frown withdrawn disinterested Frequent to constant quivering chin clenched jaw Legs
Normal position or relaxed Uneasy restless tense Kicking or legs drawn up
ACTIVITY
Lying quietly normal position moves easily Squirming shifting back and forth tense Arched rigid or jerking Cry
No cry awake or asleep Moans or whimpersoccasional complaint crying steadily screams or sobs CONSOLABILITY
Content relaxed Reassured by occasional touching hugging or being talked to distractable Difficulty to console or comfort
It will be monitored on admission and every 10 mins till discharge from the PACU 0 10 20 30 40 50 60 mins time of discharge If the FLACC pain scale score is noted at any time to be 4 or more the patient will be given1micgkg fentanyl IV and repeated after 10 mins if the participant is still in pain with a maximum total dose 2 mgkg
Time of first postoperative administration of fentanyl - in mints
Modified Aldrete score - The discharge from the PACU will be measured using Modified Aldrete score Items are -
Activity
2 able to move 4 extremities voluntarily or on command
1 able to move 2 extremities voluntarily or on command 0 unable to move extremities voluntarily or on command
Respiration
2 able to breath deeply and cough freely
1 dyspnea or limited breathing 0 apneic
Circulation
2 BP - 20 of pre-anesthetic level
1 BP - 20 to 49 of pre-anesthetic level 0 BP - 50 of pre-anesthetic level
Consciousness
2 fully awake
1 arousable on calling 0 not responding
O2 saturation
2 able to maintain O2 saturation 92 on room air
1 needs O2 inhalation to maintain O2 saturation 90 0 O2 saturation 90 even with O2 supplement It will be monitored on admission and every 10 mins till discharge from the PACU 0 10 20 30 40 50 60 mins time of discharge Participants will be discharged from the PACU after adequate control of agitation and pain and when they has achieved Modified Aldrete score characteristics of 9
Postoperative complications - All post operative complications are also recorded by the observer blinded to group allocation which include -
The occurrence of Postoperative nausea and vomiting PONV -
PONV is treated as needed with ivondansetron 006 mgkg every 4 h
The occurrence of postoperative respiratory depression defined as oxygen saturation below than 95 and respiratory rate below than 10 breathsmin
The occurrence of Postoperative Laryngospasm or Bronchospasm
The occurrence of postoperative Hypotension definition and treatment as mentioned before
The occurrence of postoperative Bradycardia definition and treatment as mentioned before
Statistical analysis
Statistical analysis will be done by using statistical package for social scientists SPSS program version 16 Data will be proved parametric by using kolmogorov -Smi mov test The quantitative data will be presented in the form of mean and standard Deviation One-way ANOVA test will be used to compare between quantitative data of the three groups Paired t-test will be used to study between two values in the same group Pain score sedation score will be represented by median and range and will be analyzed by Kruskal-Wallis test to compare between the three groups Mann-Whitney test will be used for comparison between 2 groups separately Significance will be considered when P-value is less than 005
Sample size The primary outcomes was the incidence of emergence agitation A previous study on the effect of magnesium sulfate infusion on the incidence and severity of emergence agitation in children under going adenotonsillectomy under sevoflurane anesthesia reported a 72 incidence of emergence agitation 14 We presumed that a clinically significant difference would be 50 between the incidence of agitation in the intervention and control groups With a power of 85 a 005 two-tailed the sample size was calculated to be 93 patients 31 in each group The sample size was calculated using Power Analysis and Sample Size 12 software NCSS Kay seville ut USA
The participants will be divided to 3 groups
1 Bupivacaine group B group group 1 N 31 - The participants will receive caudal block with bupivacaine 025 1mgkg diluted in 10 cm saline
IV injection of 10 cm saline over 10 mins then followed by IV infusion 50 cm saline with rate 10-20 mlh according to child weight
2 Magnesium sulfate caudal group MC group group 2 N 31 - The participants will receive caudal block with bupivacaine 025 1mgkg plus Magnesium sulfate 50 mg diluted in 10 cm saline
IV injection of 10 cm saline over 10 mins then followed by IV infusion of 50 cm saline with rate 10-20 mlh according to child weight
3 Magnesium sulfate IV group MV group group 3 N 31 - The participants will receive caudal block with bupivacaine 025 1mgkg diluted in 10 cm saline
IV injection of Magnesium sulfate 30mgkg diluted in 10 cm saline over 10 mins then followed by IV infusion one ampule of Magnesium sulfate 500mg diluted in 50 cm saline with rate 10 mgkgh
Standard monitoring is used during anesthesia and surgery include - electrocardiography non-invasive arterial pressure arterial oxygen saturation using pulse oximeter and end-tidal concentrations are measured using capnography
An intravenous line is secured before induction of anesthesia all participants will receive a standardized rapid sequence induction of anesthesia and oxygen administration for 3 minutes Anesthesia is induced with Inhalation of 8 sevoflurane without use of muscle relaxant cricoid pressure is applied and the trachea intubated with a suitable-size endotracheal tube Maintained end-tidal sevoflurane concentration will be between 25-35 and will be titrated The participants will breath spontaneously during surgery and tidal volume will be adjusted to maintain normocarbia IV injection of 02 mgkg dexamethasone after induction as a prophylaxis of post-operative nausea and vomiting of Mg sulfate Caudal block will be performed to participants before surgical incision with 1 of 2 investigators using the following technique - The Participants are placed in left lateral position after induction of general anesthesia The back of the participant including the sacral hiatus are carefully sterilized with an antiseptic solution and sterile drapes will be placed around the injection site The technique will be done by introducing a 23-gauge hypodermic needle perpendicular to the sacrococcygeal membrane with the bevel in the direction of the long fibers of the membrane The needle will be inserted until there is release of impedance as it pierced the sacrococcygeal membrane Then it is directed upwards so that it make an angle of 20-30 with the skin about 2 mm so that the whole bevel will be inside the sacral canal The injection will be made over a period of about 60 s and then a small elastoplast dressing is placed over the injection site and the participant will be placed supine Intraoperative analgesic supplement will not be given
Caudal block will be failed if HR or MAP increased 10 more than the previous basal value of beginning of surgeryparticipants will be fasting 4-6 hours for solid foods and 2 hours for clear fluids Balanced fluid therapy containing Na Cl glucose K and Ca will be infused according to body weight as follows 1st 10 kg 4 mlkghour 2nd 10 kg 2 mlkghour and 1 mlhour for every 1 kg
Then anesthetic gas discontinued and replaced O2 100 At the end of the operation the trachea is extubated The participants will be transferred to the postanesthesia care unit PACU
Intraoperative assessment-
Heart rate HR and mean arterial blood pressure MAP oxygen saturation SO2 are recorded basal before operation and every 10 mins until the end of surgery
minimal alveolar concentration MAC of sevoflurane is recorded every 10 mins
The occurrence of intraoperative hypotension defined as systolic arterial pressure 70 plus twice the age in years and associated with altered peripheral perfusion requiring a fluid bolus
The occurrence of intraoperative bradycardia defined as heart rate below 60 beats min for ages above 1 years requiring atropine
Duration of anesthesia it is the time from start of inhalation induction by sevoflurane till tracheal extubation in mins
Extubation time it is the time from termination of sevoflurane to tracheal extubation in mins
Emergence time it is the time from the end of surgery till the opening of patients eyes in mins
Interaction time it is interval between stopping sevoflurane and verbal or physical response in mins All are noted
Postoperative assessment in the PACU-
The oxygen saturation SO2 heart rate HR and mean arterial pressure MAP are monitored by the observer blinded to group allocation on admission and 10 mins till discharge 0 10 20 30 40 50 60mints time of discharge from the PACU
Emergence agitations Pediatric anesthesia emergency delirium scale PAED- The presence of Emergence agitation and its severity will be measured using PAED
Item 1 The participant makes eye contact with care giver 2 The childs actions are purposeful 3 The child is aware of hisher surroundings 4 The child is restless 5 The child is inconsolable - Items 1 2 and 3 are scored 4 not at all 3 just a little 2 quite a bit 1 very much 0 extremely
- Items 4 and 5 are scored 0 not at all 1 just a little 2 quite a bit 3 very much 4 extremely
It will be monitored on admission and every 10 mins till discharge from the PACU 0 10 20 30 40 50 60 mins time of discharge
PAED score 10 will be managed by intravenous doses of fentanyl 1micgkg repeated after 10 min if the child is still agitated with a maximum total dose of 2 micgkg PAED score 10 will be considered to be a diagnostic endpoint for the development of agitation
Pain score FLACC scale -
The presence of Pain and its severity will be measured using FLACC scale
CATEGORIES SCORING
0 1 2 Face
No particular expression or smile Occasional grimace or frown withdrawn disinterested Frequent to constant quivering chin clenched jaw Legs
Normal position or relaxed Uneasy restless tense Kicking or legs drawn up
ACTIVITY
Lying quietly normal position moves easily Squirming shifting back and forth tense Arched rigid or jerking Cry
No cry awake or asleep Moans or whimpersoccasional complaint crying steadily screams or sobs CONSOLABILITY
Content relaxed Reassured by occasional touching hugging or being talked to distractable Difficulty to console or comfort
It will be monitored on admission and every 10 mins till discharge from the PACU 0 10 20 30 40 50 60 mins time of discharge If the FLACC pain scale score is noted at any time to be 4 or more the patient will be given1micgkg fentanyl IV and repeated after 10 mins if the participant is still in pain with a maximum total dose 2 mgkg
Time of first postoperative administration of fentanyl - in mints
Modified Aldrete score - The discharge from the PACU will be measured using Modified Aldrete score Items are -
Activity
2 able to move 4 extremities voluntarily or on command
1 able to move 2 extremities voluntarily or on command 0 unable to move extremities voluntarily or on command
Respiration
2 able to breath deeply and cough freely
1 dyspnea or limited breathing 0 apneic
Circulation
2 BP - 20 of pre-anesthetic level
1 BP - 20 to 49 of pre-anesthetic level 0 BP - 50 of pre-anesthetic level
Consciousness
2 fully awake
1 arousable on calling 0 not responding
O2 saturation
2 able to maintain O2 saturation 92 on room air
1 needs O2 inhalation to maintain O2 saturation 90 0 O2 saturation 90 even with O2 supplement It will be monitored on admission and every 10 mins till discharge from the PACU 0 10 20 30 40 50 60 mins time of discharge Participants will be discharged from the PACU after adequate control of agitation and pain and when they has achieved Modified Aldrete score characteristics of 9
Postoperative complications - All post operative complications are also recorded by the observer blinded to group allocation which include -
The occurrence of Postoperative nausea and vomiting PONV -
PONV is treated as needed with ivondansetron 006 mgkg every 4 h
The occurrence of postoperative respiratory depression defined as oxygen saturation below than 95 and respiratory rate below than 10 breathsmin
The occurrence of Postoperative Laryngospasm or Bronchospasm
The occurrence of postoperative Hypotension definition and treatment as mentioned before
The occurrence of postoperative Bradycardia definition and treatment as mentioned before
Statistical analysis
Statistical analysis will be done by using statistical package for social scientists SPSS program version 16 Data will be proved parametric by using kolmogorov -Smi mov test The quantitative data will be presented in the form of mean and standard Deviation One-way ANOVA test will be used to compare between quantitative data of the three groups Paired t-test will be used to study between two values in the same group Pain score sedation score will be represented by median and range and will be analyzed by Kruskal-Wallis test to compare between the three groups Mann-Whitney test will be used for comparison between 2 groups separately Significance will be considered when P-value is less than 005
Sample size The primary outcomes was the incidence of emergence agitation A previous study on the effect of magnesium sulfate infusion on the incidence and severity of emergence agitation in children under going adenotonsillectomy under sevoflurane anesthesia reported a 72 incidence of emergence agitation 14 We presumed that a clinically significant difference would be 50 between the incidence of agitation in the intervention and control groups With a power of 85 a 005 two-tailed the sample size was calculated to be 93 patients 31 in each group The sample size was calculated using Power Analysis and Sample Size 12 software NCSS Kay seville ut USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None