| CTRI Number |
CTRI/2015/06/005842 [Registered on: 02/06/2015] Trial Registered Retrospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of propofol-fentanyl, propofol-midazolam and propofol-dexmedetomidine combination on pulse rate, blood pressure and postoperative recovery for endoscopic procedure |
|
Scientific Title of Study
|
Comparative evaluation of propofol-fentanyl, propofol-midazolam and propofol-dexmedetomidine on haemodynamic and postoperative recovery for endoscopic retrograde cholangiopancreatography: A prospective, randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No 1.0 VerProtocol Version no- 1.0 /Date- 04/04/14 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
25 Parijat Raj Kishore Nagar,
Seepat Road,
Bilaspur
25 Parijat Raj Kishore Nagar,
Seepat Road,
Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
09755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
25 Parijat Raj Kishore Nagar,
Seepat Road,
Bilaspur
25 Parijat Raj Kishore Nagar,
Seepat Road,
Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
09755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
25 Parijat Raj Kishore Nagar,
Seepat Road,
Bilaspur
25 Parijat Raj Kishore Nagar,
Seepat Road,
Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
09755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals Bilaspur |
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals Bilaspur |
| Address |
Seepat Road, Lingiadih village, Bilaspur (C.G.), India-495006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinit Kumar Srivastava |
Apollo Hospitals Bilaspur |
Department of Gastromedicine, Ground Floor, Radiology complex, Apollo Hospitals Bilaspur
Bilaspur
CHHATTISGARH
Bilaspur
CHHATTISGARH |
09755557539
drvinit75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Apollo Hospitals Bilaspur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA grade I or III patient, Non diabetic, Non hypertensive and require Endoscopic retrograde cholangiopancreatography, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
propofol-dexmedetomidine |
Dexmedetomidine 1 mcg/kg over 10 min, followed by propofol loading dose 1-2 mg/kg before procedure over a period of 2 min and maintenance infusion at a rate of 1-3 mg/kg/h throughout the procedure |
| Intervention |
propofol-fentanyl |
Fentanyl 1mcg/kg over 2 min, followed by propofol loading dose 1-2 mg/kg before procedure over a period of 2 min and maintenance infusion at a rate of 1-3 mg/kg/h throughout the procedure. |
| Intervention |
propofol-midazolam |
Midazolam 0.04mg/kg over 2 min, followed by propofol loading dose 1-2 mg/kg before procedure over a period of 2 min and maintenance infusion at a rate of 1-3 mg/kg/h throughout the procedure |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and III |
|
| ExclusionCriteria |
| Details |
1.Patients with known sensitivity to study drugs
2.History of drug or alcohol abuse,
3.Morbid obesity (body mass index>40),
4.History of chronic pain or daily intake of analgesics
5.Oral anticoagulant use (warfarin)
6.Patients with bleeding diathesis
7.Impaired kidney or endocrinal functions
8.Pregnant patients and
9.Psychiatric patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation (SpO2) |
Basal, After study drug, After induction, at various time intervals during procedure, After procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total dose of propofol,Postoperative recovery in between two groups (modified Aldrete score) and any complication
|
During and After procedure |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/05/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Srivastava VK, Singh D, Agrawal S, Khan S, Gupta A, Miree RD. Comparative Evaluation of Propofol Fentanyl, Propofol-Midazolam and Propofol-Dexmedetomidine on Haemodynamic and Postoperative Recovery for Endoscopic Retrograde Cholangiopancreatography.J Clin Diagn Res. 2018 Jul,12(7): UC01-UC05 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Endoscopic retrograde cholangiopancreatography (ERCP) is generally performed under conscious sedation. Current drugs include benzodiazepines with an opioid, with or without propofol. in recent years, dexmedetomidine has been used as an alternative to midazolam in conscious sedation. Hence the present study is designed to evaluate and compare the efficacy of propfol-midazolam, propofol-fentanyl and propofol-dexmedetomidine combination on hemodynamics and postoperative recovery in ERCP patients. All selected patients will be randomized in to three groups (31 in each group) Group I - Fentanyl 1mcg/kg over 2 min, followed by propofol loading dose 1-2 mg/kg before procedure over a period of 5 min and maintenance infusion at a rate of 1-3 mg/kg/hr throughout the procedure Group II - Midazolam 0.04mg/kg over 2 min, followed by propofol loading dose 1-2 mg/kg before procedure over a period of 5 min and maintenance infusion at a rate of 1-3 mg/kg/hr throughout the prcedure Group III - Dexmedetomidine 1mcg/kg over 10 min, followed by propofol loading dose 1-2 mg/kg before procedure over a period of 5 min and maintenance infusion at a rate of 1-3 mg/kg/hr throughout the procedure The following parameters were recoreded- 1) Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation at various intervals 2) Total dose of propofol 3) Postoperative recovery in between three groups 4) Ant complication All data will be recorded and statistically analysed. |