Ignite Creation Date:
2024-05-06 @ 7:08 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02475824
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2015-06-14
Brief Title:
Midazolam With Meperidine and Dexmedetomidine vs Midazolam With Meperidine and Propofol for Sedation During ERCP
Sponsor:
Dankook University
Organization:
Dankook University
Study Overview
Official Title:
A Randomized Comparison of Midazolam With Meperidine and Dexmedetomidine Versus Midazolam With Meperidine and Propofol for Sedation During ERCP
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
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:
This is a single-center prospective randomized double-blinded study of consecutive patients referred for ERCP A recent study suggested that the addition of dexmedetomidine to the midazolam-meperidine regimen MMDprovided better sedative efficacy and a superior safety profile during ERCP compared with a midazolam-meperidine regimen Further study is warranted to compare an MMD regimen with propofol-based regimen
Randomization is performed by use of a computer-generated random allocations in a ratio of 11 in balanced blocks of 4 A separate sedating nurse who dont participate in the study is the only person with knowledge of the sedation regimen This separate nurse repeated the injection of propofol and completed questionnaires
Randomization is performed by use of a computer-generated random allocations in a ratio of 11 in balanced blocks of 4 A separate sedating nurse who dont participate in the study is the only person with knowledge of the sedation regimen This separate nurse repeated the injection of propofol and completed questionnaires
Detailed Description:
Study design This is a single-center prospective randomized double-blinded study of consecutive patients referred for ERCP Randomization is performed by use of a computer-generated random allocations in a ratio of 11 in balanced blocks of 4 A separate sedating nurse who dont participate in the study is the only person with knowledge of the sedation regimen This separate nurse repeated the injection of propofol and completed questionnaires
Inclusion criteria include consecutive patients who are scheduled for ERCP and those are aged 18-80 years ASA class I-III Exclusion criteria are as follows
1 patient age 18years 2 pregnancy 3 American Society of Anesthesiology ASA physical status class IV V 4 history of allergies to drug used 6 history of complications with previous sedation 5 hypoxemia baseline SaO2 90 6 hypotension baseline systolic blood pressure 90mmHg 7 severe bradycardia heart rate 50min andor brady-dysrhythmias eg advanced heart block 8 impaired ventricular function left ventricular ejection fraction 30 9 baseline respiratory rate 25 or 10 breathsmin and 10 inability to provide informed consent Patients are excluded from the final analysis if the procedure is terminated early or abandoned for anatomical reasons ie duodenal obstruction or gastrectomy
Sedation protocols After randomization patients are allocated to group 1 or 2 and prepared for endoscopy
All sedatives and analgesics used for the study are administered by trained sedative nurse under endoscopist supervision All participants receive an IV bolus dose of midazolam 006mgkg 50 reduction for patients if age 70 or ASA class III-IV Bukwang Pharm Co Seoul Republic of Korea and meperidine 50mg 25mg for patients aged 70 years pethidine HCL Hana Pharm Co Seoul Republic of Korea Repeated doses of 10-20 mg propofol are titrated to achieve the target level of sedation Maintenance of sedation is achieved with repeated doses of 5 to 20 mg propofol The total dosage of propofol including additional doses is limited by lower and upper bounds of 10mg and 100mg respectively The target level of sedation is moderate sedation based on the ASA levels
For the patients allocated to the midazolam-meperidine-dexmedetomidine MMD group both midazolam 005 mgkg 30 reduction for patients if age 70 or ASA class III-IV Bukwang Pharm Co Seoul Republic of Korea and meperidine 50mg 25mg for patients aged 70 years pethidine HCL Hana Pharm Co Seoul Republic of Korea are given intravenously at the initiation of sedation In addition a continuous IV infusion of dexmedetomidine 1ugkgh Precedex Hospira Seoul Republic of Korea is administered 15 min before the ERCP till complete the procedure Thereafter repeated doses of 1 to 2 mg midazolam are administered to maintain a moderate level of sedation For the patients allocated to the midazolam-meperidine-propofol BPS group both midazolam and meperidine are given at the initiation of sedation in the same manner as in the MMD group
Thereafter repeated doses of 10-20 mg propofol are titrated to achieve the target level of sedation Maintenance of sedation is achieved with repeated doses of 5 to 20 mg propofol The total dosage of propofol including additional doses is limited by lower and upper bounds of 10mg and 100mg respectively The target level of sedation is moderate sedation based on the ASA levels
Medications and monitoring Intranasal supplemental oxygen 2Lmin is provided to all participants at the initiation of sedation Heart rate electrocardiogram peripheral oxygen saturation SaO2 respiratory rate and end-tidal carbon dioxide EtCo2 are constantly monitored Non-invasive blood pressure NIBP is automatically measured at 3-minute intervals Sedation level is assessed and recorded every 3 minutes throughout the procedure with the Modified Observers Assessment of Alertness and Sedation MOAAS Patients are considered to be oversedated at MOAAS score 1
MOAAS Modified Observes Assessment of Alertness and Sedation 5-responds readily to name spoken in normal tone 4-lethargic response to name spoken in normal tone 3-responds only after name is called loudly andor repeatedly 2-responds only after mild prodding or shaking 1-does not respond to mild prodding or shaking 0-does not respond to noxious stimulus
If hypoxemia SpO290 is observed during sedation in either group O2 supplementation is increased by 2Lmin until oxygen saturation is restored If the SpO2 dropped to 85 for 30 sec despite patient stimulation and interruption of sedatives and jaw thrust maneuver an antagonist to midazolam flumazenil could be injected and the procedure is interrupted until normalization of oxygen saturation occurred again
During recovery the patients vital signs NIBP SpO2 heart rate sedation level Gillham scale and speed of recovery modified Aldrete score are recorded at 5-minute intervals until discharge from the recovery room
Gillham sedation scale 1-awake and anxious 2-awake not anxious 3-speech slurred 4-eyes closed responds to speech 5-eye closed responds to shaking 6-unresponsive
Outcome measurements and definitions The primary endpoint of the study is the rates of cardiopulmonary complications and the frequency of interruption of the ERCP procedures because of complications included 1 hypoxemia pulse oximeter oxygen saturation below 90 on supplemental oxygen 2 hypotension systolic blood pressure below 90 mmHg 3 bradycardia heart rate below 50 beatsmin Procedure quality is evaluated based on therapeutic procedure outcomes including technical success and total procedure time and procedure-related adverse events If transient interruptions of the procedure occurred because of sedation-related complications that time is subtracted from the procedure time
The endoscopist blinded to the method of sedation The secondary endpoints are the ease of ERCP performance speed of recovery and patient satisfaction with sedation
At the end of the procedure the ease of performance of ERCP is evaluated by the endoscopist using structured questionnaires
If full recovery is confirmed in the inpatient setting patient satisfaction with sedation and pain intensity during ERCP are assessed by another independent assistant using a 10-cm VAS scale 0no painno satisfaction 10worst painfull satisfaction
Inclusion criteria include consecutive patients who are scheduled for ERCP and those are aged 18-80 years ASA class I-III Exclusion criteria are as follows
1 patient age 18years 2 pregnancy 3 American Society of Anesthesiology ASA physical status class IV V 4 history of allergies to drug used 6 history of complications with previous sedation 5 hypoxemia baseline SaO2 90 6 hypotension baseline systolic blood pressure 90mmHg 7 severe bradycardia heart rate 50min andor brady-dysrhythmias eg advanced heart block 8 impaired ventricular function left ventricular ejection fraction 30 9 baseline respiratory rate 25 or 10 breathsmin and 10 inability to provide informed consent Patients are excluded from the final analysis if the procedure is terminated early or abandoned for anatomical reasons ie duodenal obstruction or gastrectomy
Sedation protocols After randomization patients are allocated to group 1 or 2 and prepared for endoscopy
All sedatives and analgesics used for the study are administered by trained sedative nurse under endoscopist supervision All participants receive an IV bolus dose of midazolam 006mgkg 50 reduction for patients if age 70 or ASA class III-IV Bukwang Pharm Co Seoul Republic of Korea and meperidine 50mg 25mg for patients aged 70 years pethidine HCL Hana Pharm Co Seoul Republic of Korea Repeated doses of 10-20 mg propofol are titrated to achieve the target level of sedation Maintenance of sedation is achieved with repeated doses of 5 to 20 mg propofol The total dosage of propofol including additional doses is limited by lower and upper bounds of 10mg and 100mg respectively The target level of sedation is moderate sedation based on the ASA levels
For the patients allocated to the midazolam-meperidine-dexmedetomidine MMD group both midazolam 005 mgkg 30 reduction for patients if age 70 or ASA class III-IV Bukwang Pharm Co Seoul Republic of Korea and meperidine 50mg 25mg for patients aged 70 years pethidine HCL Hana Pharm Co Seoul Republic of Korea are given intravenously at the initiation of sedation In addition a continuous IV infusion of dexmedetomidine 1ugkgh Precedex Hospira Seoul Republic of Korea is administered 15 min before the ERCP till complete the procedure Thereafter repeated doses of 1 to 2 mg midazolam are administered to maintain a moderate level of sedation For the patients allocated to the midazolam-meperidine-propofol BPS group both midazolam and meperidine are given at the initiation of sedation in the same manner as in the MMD group
Thereafter repeated doses of 10-20 mg propofol are titrated to achieve the target level of sedation Maintenance of sedation is achieved with repeated doses of 5 to 20 mg propofol The total dosage of propofol including additional doses is limited by lower and upper bounds of 10mg and 100mg respectively The target level of sedation is moderate sedation based on the ASA levels
Medications and monitoring Intranasal supplemental oxygen 2Lmin is provided to all participants at the initiation of sedation Heart rate electrocardiogram peripheral oxygen saturation SaO2 respiratory rate and end-tidal carbon dioxide EtCo2 are constantly monitored Non-invasive blood pressure NIBP is automatically measured at 3-minute intervals Sedation level is assessed and recorded every 3 minutes throughout the procedure with the Modified Observers Assessment of Alertness and Sedation MOAAS Patients are considered to be oversedated at MOAAS score 1
MOAAS Modified Observes Assessment of Alertness and Sedation 5-responds readily to name spoken in normal tone 4-lethargic response to name spoken in normal tone 3-responds only after name is called loudly andor repeatedly 2-responds only after mild prodding or shaking 1-does not respond to mild prodding or shaking 0-does not respond to noxious stimulus
If hypoxemia SpO290 is observed during sedation in either group O2 supplementation is increased by 2Lmin until oxygen saturation is restored If the SpO2 dropped to 85 for 30 sec despite patient stimulation and interruption of sedatives and jaw thrust maneuver an antagonist to midazolam flumazenil could be injected and the procedure is interrupted until normalization of oxygen saturation occurred again
During recovery the patients vital signs NIBP SpO2 heart rate sedation level Gillham scale and speed of recovery modified Aldrete score are recorded at 5-minute intervals until discharge from the recovery room
Gillham sedation scale 1-awake and anxious 2-awake not anxious 3-speech slurred 4-eyes closed responds to speech 5-eye closed responds to shaking 6-unresponsive
Outcome measurements and definitions The primary endpoint of the study is the rates of cardiopulmonary complications and the frequency of interruption of the ERCP procedures because of complications included 1 hypoxemia pulse oximeter oxygen saturation below 90 on supplemental oxygen 2 hypotension systolic blood pressure below 90 mmHg 3 bradycardia heart rate below 50 beatsmin Procedure quality is evaluated based on therapeutic procedure outcomes including technical success and total procedure time and procedure-related adverse events If transient interruptions of the procedure occurred because of sedation-related complications that time is subtracted from the procedure time
The endoscopist blinded to the method of sedation The secondary endpoints are the ease of ERCP performance speed of recovery and patient satisfaction with sedation
At the end of the procedure the ease of performance of ERCP is evaluated by the endoscopist using structured questionnaires
If full recovery is confirmed in the inpatient setting patient satisfaction with sedation and pain intensity during ERCP are assessed by another independent assistant using a 10-cm VAS scale 0no painno satisfaction 10worst painfull satisfaction
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