| CTRI Number |
CTRI/2018/04/013180 [Registered on: 11/04/2018] Trial Registered Prospectively |
| Last Modified On: |
08/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of fentanyl and buprenorphine on pulse and blood pressure during laryngoscopy and intubation |
|
Scientific Title of Study
|
A comparative study of hemodynamic response to laryngoscopy and intubation: fentanyl versus buprenorphine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikash Kumar |
| Designation |
MD(junior resident) |
| Affiliation |
Indira gandhi institue of medical science, patna |
| Address |
Department of anaesthesia, first floor, ward block, IGIMS Campus, Patna
Patna
BIHAR
800014
India |
| Phone |
8271837270 |
| Fax |
|
| Email |
kumardrvikash06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K H Raghwendra |
| Designation |
MD(Professor) |
| Affiliation |
Indira gandhi institue of medical science, patna |
| Address |
Department of anaesthesia,
IGIMS, Patna
E-1/3,IGIMS Campus, patna
Patna
BIHAR
800014
India |
| Phone |
9835092798 |
| Fax |
|
| Email |
dr.khraghwendra@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Kumar |
| Designation |
MD(Professor) |
| Affiliation |
Indira gandhi institue of medical science, patna |
| Address |
Department of anaesthesia,
IGIMS, Patna
D-1/2,IGIMS Campus, patna
Patna
BIHAR
800014
India |
| Phone |
9473191829 |
| Fax |
|
| Email |
sanjeev_pranay71@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia,IGIMS, Patna |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia |
| Address |
First floor,IGIMS,sheikhpura,Raza bazar, patna |
| Type of Sponsor |
Government medical college |
|
|
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 Vikash Kumar |
Indira gandhi institute of medical science, patna |
OT Complex, first floor, ward block,IGIMS Campus,Patna
Patna
BIHAR |
8271837270
kumardrvikash06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, IGIMS,Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1&2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
buprenorphine |
Dose-buprenorphine @ 2.5 mcg/kg Route-Intravenous Frequency-1 |
| Comparator Agent |
Fentanyl |
Dose-fentanyl@2mcg/kg Route-intravenous Frequency-1 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Wt. 20 to 70 kg
ASA grade-1&2
Malampatti grade- 1&2
Conscious & co-operative patient
|
|
| ExclusionCriteria |
| Details |
Age <18 years or >70 years
Wt.<20 kg or >70 kg
ASA grade >3
Difficult intubation (MGP 3 or more)
Non co-operative patient
any contraindication to opiods
patient on beta blocker
allergy to drug
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparision of hemodynamic attenuation between fentanyl and buprenorphine premedication |
1,3,5,10,15 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any adverse effect of drug |
after 5 minutes of drug |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/04/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/11/2019 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Plan to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a comparative study between fentanyl and buprenorphine for attenuation of hemodynamic response to intubation and laryngoscopy |