Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545890
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Ketofol Versus Dexmedetomidine for Prevention of Emergence Delirium in Pediatric Patients Undergoing Squint Surgeries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ketofol Versus Dexmedetomidine for Prevention of Emergence Delirium in Pediatric Patients Undergoing Squint Surgeries A Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to compare the effectiveness of ketofol for the prevention of emergence delirium in pediatric patients undergoing squint surgery in comparison to dexmedetomidine
Detailed Description:
To compare the incidence of ED between children who received ketofol with those who received dexmedetomidine
To compare the adverse effect profile associated with both drugs regarding the effect on heart rate mean arterial pressure recovery time nausea and vomiting
Hypothesis
We hypothesize that Ketofol due to the combined effect of ketamine and propofol will be as effective as dexmedetomidine in preventing ED in pediatric patients undergoing squint surgery
Ethical Considerations
The study protocol will be implemented after the approval by the Institutional Research Ethics Committee and then written informed consent will be obtained from all patients before enrollment into the study
Methodology
I Study design
A prospective randomized controlled double blinded study
II Study setting and location
The study will be conducted at the Specialized Children Hospital Abo El-Rish
Cairo University
III Study population
All pediatric patients aged 2 to 6 years with ASA physical status I and II scheduled for squint surgery will be included in the study
IV Eligibility Criteria 1 Inclusion criteria
All pediatric patients aged 2 to 6 years
Both sexes
ASA physical status I and II
Patients undergoing squint surgery
2 Exclusion criteria
Refusal of parents
Patient sensitivity to any of the study medications
Known neurological disease that can affect the assessment of ED postoperatively
V Study Procedures 1 Randomization in RCT only
A computer-generated sequence will be used for randomization and opaque envelopes will be used for concealment
The investigator is the anesthesiologist who will prepare all the syringes with the study drugs and will prepare them in wrapped aluminum foils and sealed opaque envelope technique which will be provided to another investigator just before administering them to the children Monitoring and data collection will be done by a resident who is unaware of the study drugs and allocation
Study Protocol
All patients meeting the inclusion criteria will be assessed for adequate fasting except for oral clear liquids intake 2 hours before surgery all children will fast for 6 hours Patients will attend in the preparation room one hour before the operation to get a preoperative checkup as well as their age and body weight will be recorded Premedicated by intramuscular injection of atropine 002 mgKg and midazolam 02 mgKg On arriving the operating room standard monitors including SpO2 ECG and noninvasive blood pressure Dräger infinity vista XL will be applied Inhalational induction using Sevoflurane 5 will be performed and after the loss of consciousness intravenous cannula will be inserted Atropine 001 mgkg will be administered and appropriate sized endotracheal tube will be inserted after muscle relaxation using atracurium 05 mgkg Maintenance of anesthesia using 2 Sevoflurane in 50 O2 will be started and its dose will be adjusted according to the measured pulse and mean arterial pressure MAP which was kept within 20 of their basal values with the goal of keeping the BIS measurement between 40-60 and atracurium top-ups of 01mgkg was given every 30 minutes for neuromuscular blockade and controlled ventilation will be applied aiming for EtCO2 to be between 32-34 mmHg using GE-Datex-Ohmeda Avance CS2 USA anesthesia machine Then patients will be randomized to either group A or group B
Group A
Five minutes after securing the airway dexmedetomidine infusion will be started at a rate of 02 mcgkghr
Group B
Five minutes after induction Ketofol ketamine to propofol ratio 14 will be infused at a rate of 06 mlkghr Ketofol will be prepared by adding 40 mg of ketamine to 160 mg of propofol and diluted to 20 ml with normal saline 09
The hemodynamic data including heart rate and arterial pressure will be documented every five minutes and any intraoperative complications including bradycardia hypotension will be managed and documented Ten minutes before the conclusion of the surgery the infusion in both groups will be stopped All patients will receive 15mgkg paracetamol IV
After finishing the surgical procedure sevoflurane will be discontinued and the neuromuscular block will be reversed via neostigmine 005 mgkg and atropine 002 mgkg The patient will be extubated when heshe is fully awake expressing eye-opening and purposeful movement in addition to maintaining good tidal volume Then the patients will be transferred to the PACU where they receive O2 via a face mask to maintain oxygen saturation above 95
During their stay at PACU delirium will be assessed at 5 10 15 20 25 and 30 minutes following extubation via the Pediatric Anesthesia Emergence Delirium scale PAED Table 1 and ED will be established when the child have a score of 10 or more If the child has a score of 10 or more rescue sedation will be done via propofol 1 mgkg 1417
The postoperative pain will be assessed via the Face Legs Activity Cry and Consolability FLACC scale 0 Relaxed and comfortable1-3 Mild discomfort 4-6 Moderate pain 7-10 Severe discomfortpain IV Fentanyl 1 μgm kg will be administered if the child expressed a score of 3 or more 16
Criteria
Not at all
Just a little
Quite a bit
Very much
Extremely
Score
The child makes eye contact with the caregiverparent
4
3
2
1
0
The childs actions are purposeful
4
3
2
1
0
The child is aware of hisher surrounding
4
3
2
1
0
The child is restless
0
1
2
3
4
The child is inconsolable
0
1
2
3
4
Total score
Table 1 Pediatric Anesthesia Emergence Delirium PAED Scale Score The PAED scale consists of 5 criteria that are scored using a 5-point scale The scores of each criterion are added to make a total score The maximum achievable score is 20 A score of 10 has 64 sensitivity and 86 specificity for the diagnosis of ED A score of 12 100 sensitivity and 945 specificity for the diagnosis of ED 17
Both pulse and MAP will be recorded at PACU on arrival then at 5 and 10 minutes then every 10 minutes until the discharge
Any postoperative complications including bradycardia hypotension or hypersensitivity reaction will be recorded The incidence of postoperative vomiting together with the duration of stay in PACU will be recorded
Children were monitored in the PACU for all the above parameters until discharge and criteria of discharge are
1 Fully awake
2 Calm
3 Stable hemodynamics
4 PAED scale 10
5 Oxygen saturation 92 on room air
VI Study outcomes
1 Primary outcome
The incidence of postoperative ED using PAED scale at time of admission to PACU in both groups
2 Secondary outcomes
Intraoperative vital signs So2 HR bpm and MAP mmhg on admission to OR and every 5 minutes intraoperative
Incidence of Intraoperative complications bradycardia and hypotension
PAED scale at 5 10 15 20 25 and 30 minutes after extubation
Total dose of rescue sedation by propofol mg at PACU
FLACC scale at PACU
Total dose of rescue analgesia mic
Postoperative hemodynamics So2 HR bpm and MAP mmhg after 5 and 10 minutes after admission to PACU then every 10 minutes till discharge
Incidence of postoperative nausea and vomiting
Length of stay in the PACU minutes
Statistical Analysis
I Sample size
Sample size was calculated using GPower version 3192 Kiel University Kiel Germany software based on our primary outcome ED could occur in dexmedetomidine group and ketofol group with PAED score 1552195 and 4703988 respectively 8 a total sample of 46 patients 23 in each group were required to achieve a power 1-β of 90 and type I α error of 005 Six patients were added to compensate for any drop out Thus the final sample was 26 patients in each group with total 52 patients
II Statistical analysis
To compare the adverse effect profile associated with both drugs regarding the effect on heart rate mean arterial pressure recovery time nausea and vomiting
Hypothesis
We hypothesize that Ketofol due to the combined effect of ketamine and propofol will be as effective as dexmedetomidine in preventing ED in pediatric patients undergoing squint surgery
Ethical Considerations
The study protocol will be implemented after the approval by the Institutional Research Ethics Committee and then written informed consent will be obtained from all patients before enrollment into the study
Methodology
I Study design
A prospective randomized controlled double blinded study
II Study setting and location
The study will be conducted at the Specialized Children Hospital Abo El-Rish
Cairo University
III Study population
All pediatric patients aged 2 to 6 years with ASA physical status I and II scheduled for squint surgery will be included in the study
IV Eligibility Criteria 1 Inclusion criteria
All pediatric patients aged 2 to 6 years
Both sexes
ASA physical status I and II
Patients undergoing squint surgery
2 Exclusion criteria
Refusal of parents
Patient sensitivity to any of the study medications
Known neurological disease that can affect the assessment of ED postoperatively
V Study Procedures 1 Randomization in RCT only
A computer-generated sequence will be used for randomization and opaque envelopes will be used for concealment
The investigator is the anesthesiologist who will prepare all the syringes with the study drugs and will prepare them in wrapped aluminum foils and sealed opaque envelope technique which will be provided to another investigator just before administering them to the children Monitoring and data collection will be done by a resident who is unaware of the study drugs and allocation
Study Protocol
All patients meeting the inclusion criteria will be assessed for adequate fasting except for oral clear liquids intake 2 hours before surgery all children will fast for 6 hours Patients will attend in the preparation room one hour before the operation to get a preoperative checkup as well as their age and body weight will be recorded Premedicated by intramuscular injection of atropine 002 mgKg and midazolam 02 mgKg On arriving the operating room standard monitors including SpO2 ECG and noninvasive blood pressure Dräger infinity vista XL will be applied Inhalational induction using Sevoflurane 5 will be performed and after the loss of consciousness intravenous cannula will be inserted Atropine 001 mgkg will be administered and appropriate sized endotracheal tube will be inserted after muscle relaxation using atracurium 05 mgkg Maintenance of anesthesia using 2 Sevoflurane in 50 O2 will be started and its dose will be adjusted according to the measured pulse and mean arterial pressure MAP which was kept within 20 of their basal values with the goal of keeping the BIS measurement between 40-60 and atracurium top-ups of 01mgkg was given every 30 minutes for neuromuscular blockade and controlled ventilation will be applied aiming for EtCO2 to be between 32-34 mmHg using GE-Datex-Ohmeda Avance CS2 USA anesthesia machine Then patients will be randomized to either group A or group B
Group A
Five minutes after securing the airway dexmedetomidine infusion will be started at a rate of 02 mcgkghr
Group B
Five minutes after induction Ketofol ketamine to propofol ratio 14 will be infused at a rate of 06 mlkghr Ketofol will be prepared by adding 40 mg of ketamine to 160 mg of propofol and diluted to 20 ml with normal saline 09
The hemodynamic data including heart rate and arterial pressure will be documented every five minutes and any intraoperative complications including bradycardia hypotension will be managed and documented Ten minutes before the conclusion of the surgery the infusion in both groups will be stopped All patients will receive 15mgkg paracetamol IV
After finishing the surgical procedure sevoflurane will be discontinued and the neuromuscular block will be reversed via neostigmine 005 mgkg and atropine 002 mgkg The patient will be extubated when heshe is fully awake expressing eye-opening and purposeful movement in addition to maintaining good tidal volume Then the patients will be transferred to the PACU where they receive O2 via a face mask to maintain oxygen saturation above 95
During their stay at PACU delirium will be assessed at 5 10 15 20 25 and 30 minutes following extubation via the Pediatric Anesthesia Emergence Delirium scale PAED Table 1 and ED will be established when the child have a score of 10 or more If the child has a score of 10 or more rescue sedation will be done via propofol 1 mgkg 1417
The postoperative pain will be assessed via the Face Legs Activity Cry and Consolability FLACC scale 0 Relaxed and comfortable1-3 Mild discomfort 4-6 Moderate pain 7-10 Severe discomfortpain IV Fentanyl 1 μgm kg will be administered if the child expressed a score of 3 or more 16
Criteria
Not at all
Just a little
Quite a bit
Very much
Extremely
Score
The child makes eye contact with the caregiverparent
4
3
2
1
0
The childs actions are purposeful
4
3
2
1
0
The child is aware of hisher surrounding
4
3
2
1
0
The child is restless
0
1
2
3
4
The child is inconsolable
0
1
2
3
4
Total score
Table 1 Pediatric Anesthesia Emergence Delirium PAED Scale Score The PAED scale consists of 5 criteria that are scored using a 5-point scale The scores of each criterion are added to make a total score The maximum achievable score is 20 A score of 10 has 64 sensitivity and 86 specificity for the diagnosis of ED A score of 12 100 sensitivity and 945 specificity for the diagnosis of ED 17
Both pulse and MAP will be recorded at PACU on arrival then at 5 and 10 minutes then every 10 minutes until the discharge
Any postoperative complications including bradycardia hypotension or hypersensitivity reaction will be recorded The incidence of postoperative vomiting together with the duration of stay in PACU will be recorded
Children were monitored in the PACU for all the above parameters until discharge and criteria of discharge are
1 Fully awake
2 Calm
3 Stable hemodynamics
4 PAED scale 10
5 Oxygen saturation 92 on room air
VI Study outcomes
1 Primary outcome
The incidence of postoperative ED using PAED scale at time of admission to PACU in both groups
2 Secondary outcomes
Intraoperative vital signs So2 HR bpm and MAP mmhg on admission to OR and every 5 minutes intraoperative
Incidence of Intraoperative complications bradycardia and hypotension
PAED scale at 5 10 15 20 25 and 30 minutes after extubation
Total dose of rescue sedation by propofol mg at PACU
FLACC scale at PACU
Total dose of rescue analgesia mic
Postoperative hemodynamics So2 HR bpm and MAP mmhg after 5 and 10 minutes after admission to PACU then every 10 minutes till discharge
Incidence of postoperative nausea and vomiting
Length of stay in the PACU minutes
Statistical Analysis
I Sample size
Sample size was calculated using GPower version 3192 Kiel University Kiel Germany software based on our primary outcome ED could occur in dexmedetomidine group and ketofol group with PAED score 1552195 and 4703988 respectively 8 a total sample of 46 patients 23 in each group were required to achieve a power 1-β of 90 and type I α error of 005 Six patients were added to compensate for any drop out Thus the final sample was 26 patients in each group with total 52 patients
II Statistical analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None