| CTRI Number |
CTRI/2023/10/058770 [Registered on: 17/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of efficacy of nalbuphine and fentanyl as an adjuvant to spinal Anesthesia in lower abdominal surgeries |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of nalbuphine and fentanyl as an adjuvant to intrathecal bupivacaine in lower abdominal surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anand S |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Room no 009,Department of Anaesthesiology
Saveetha medical college and hospital
Chennai
TAMIL NADU
602105
India |
| Phone |
9600055126 |
| Fax |
|
| Email |
dranandanesthesia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrLatha |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of anaesthesiology
Saveetha medical college and hospital
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9840125462 |
| Fax |
|
| Email |
lathanarayanan2363@gmail.Com |
|
Details of Contact Person
Public Query
|
| Name |
DrLatha |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of anaesthesiology
Saveetha medical college and hospital
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9840125462 |
| Fax |
|
| Email |
lathanarayanan2363@gmail.Com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital Chennai |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Department of anaesthesiology
Saveetha medical college and hospital
Thandalam |
| 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 |
| Anand |
Saveetha medical college and hospital, chennai |
Saveetha nagar , Thandalam,
Chennai Bengaluru NH 48
Chennai
TAMIL NADU |
9600055126
dranandanesthesia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Posted for elective lower abdominal surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical 1 and 2 |
|
| ExclusionCriteria |
| Details |
Pregnant women
Allergy to amides
Known case of obstructive sleep apnoea |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the analgesic efficacy of nalbuphine and fentanyl as an adjuvant to intrathecal bupivacaine in lower abdominal surgeries |
Intraopratively BP and PR MEASURED AT 0,1,5,10,15,20,30,60,120 mins
Post operatively PR and BP EVERY 20 mins for 2 hours
Post operative VAS SCORE in 2,4,6,12 and 24 hours
PATIENT SATISFACTION SCORE
DURATION OF ONSET OF MOTOR POWER IN 3,4,5,6,7,8,9 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative hemodynamics, VASscore and PATIENT SATISFACTION SCORE |
Intraopratively BP and PR MEASURED AT 0,1,5,10,15,20,30,60,120 mins
Post operatively PR and BP EVERY 20 mins for 2 hours
Post operative VAS SCORE in 2,4,6,12 and 24 hours
PATIENT SATISFACTION SCORE
DURATION OF ONSET OF MOTOR POWER IN 3,4,5,6,7,8,9 hours. |
|
|
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)
|
17/10/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study We would like to compare the efficacy of intrathecal nalbuphine and fentanyl as an adjuvant to bupivacaine in lower abdominal surgeries. Intraopratively BP and PR MEASURED AT 0,1,5,10,15,20,30,60,120 mins Post operatively PR and BP EVERY 20 mins for 2 hours Post operative VAS SCORE in 2,4,6,12 and 24 hours PATIENT SATISFACTION SCORE DURATION OF ONSET OF MOTOR POWER IN 3,4,5,6,7,8,9 hours. Thank you |