| CTRI Number |
CTRI/2019/10/021537 [Registered on: 07/10/2019] Trial Registered Prospectively |
| Last Modified On: |
03/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study of analgesic and hemodynamic effect of nalbuphine vs fentanyl, a randomized double blind Interventional Study On Cardiac Surgical Patients |
|
Scientific Title of Study
|
Comparison of analgesic and hemodynamic effect of nalbuphine vs fentanyl :A randomized double blind Interventional Study on cardiac surgical patients at SMS medical college and attached hospitals, Jaipur during 2018-2019 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ANJUM SAIYED |
| Designation |
SENIOR PROFFESOR |
| Affiliation |
sms medical college jaipur |
| Address |
Department of anesthesiology, 2nd floor, dhanwantari building, SMS Medical college ,jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
dranjumsaiyed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANJUM SAIYED |
| Designation |
SENIOR PROFFESOR |
| Affiliation |
sms medical college jaipur |
| Address |
Department of anesthesiology, 2nd floor, dhanwantari building, SMS Medical college ,jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
dranjumsaiyed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SAURABH KUMAR SHARMA |
| Designation |
PG STUDENT |
| Affiliation |
sms medical college jaipur |
| Address |
Department of anesthesiology, 2nd floor, dhanwantari building, SMS Medical college ,jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8955369252 |
| Fax |
|
| Email |
drsharmask12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology, 2nd floor, dhanwantari building, SMS Medical college ,jaipur |
|
|
Primary Sponsor
|
| Name |
Department of anesthesiologySMS medical college jaipur |
| Address |
Department of anesthesiology, 2nd floor,dhanwantari building,SMS Medical college,jaipur |
| 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 Anjum saiyed |
sms medical college and hospital Jaipur |
Department of Anaesthisiology
Near ot complex 2nd floor, dhanwantari bhawan, jaipur
Jaipur
RAJASTHAN |
9214021930
dranjumsaiyed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sms medical college ethics Committee jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I39||Endocarditis and heart valve disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
iv inj fentanyl |
30 patients will receive inj. fentanyl 3 microgm/kg iv slowly 5 minutes before induction and thereafter repeated if BIS SCORE more than 60 during surgery. |
| Intervention |
iv inj nalbuphine |
30 patients will receive inj. nalbuphine 0.2mg/kg iv slowly 5 minutes before induction and thereafter repeated if BIS SCORE more than 60 during surgery. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Either sex
2. Age group 18-65yrs
3 .Body weight 40-70kg
4. ASA Grade II &lll
5. Scheduled for cardiac surgery on cardiopulmonary bypass
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in study
2. Uncooperative patients
3. Patients with history of drug allergy
4. Patients with pre-existing, Asthma, Renal or Hepatic dysfunction
5. Morbid obese patient
6. Pregnancy/Lactation
|
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare hemodynamic variables from baseline at different time interval in both groups.
Heart rate
Systolic blood pressure
Diastolic blood pressure
Mean Arterial Pressure
central venous pressure
|
Data will be recorded baseline (before induction), just after intubation, 5 min and 15 min, 30 min after intubation nd after that 5 min before going on pump, 5 min after going on pump, every 30 min till shifted to icu. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.To asses and compare BIS guided total requirement of analgesic drug in bothgroups
2.To assess and compare the time required for first rescue analgesic in both group in postoperative period after extubation according to VAS score.
3.To compare side effects and complications of both drugs.
|
After extubation ,post operative analgesia evaluted by visual analogue scale (VAS)in every 30 mins till vas more then 3 |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study we aim to compare the effect of nalbuphine and fentanyl on hemodynamic parameters and BIS guided total analgesic dose required,time required of first rescue analgesic and side effects any. |