| CTRI Number |
CTRI/2024/01/061656 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
14/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study is being done to compare the analgesic and hemodynamic effect of administration of Fentanyl, an opioid analgesic mixed with Bupivacaine, a Local Anaesthetic for Spinal Anaesthesia using two different methods in patients undergoing Lower Abdominal Surgeries. |
|
Scientific Title of Study
|
Comparison of efficacy of hyperbaric bupivacaine pre-mixed with fentanyl versus sequential administration of fentanyl followed by hyperbaric bupivacaine in lower abdominal surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagnik Datta Majumdar |
| Designation |
Junior Resident |
| Affiliation |
Chirayu Medical College and Hospital |
| Address |
Department of Anaesthesiology
Chirayu Medical College and Hospital
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9754151325 |
| Fax |
|
| Email |
sagnikdattamajumdar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Trivedi |
| Designation |
Assistant Professor |
| Affiliation |
Chirayu Medical College and Hospital |
| Address |
Department of Anaesthesiology
Chirayu Medical College and Hospital
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7042461338 |
| Fax |
|
| Email |
drst23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagnik Datta Majumdar |
| Designation |
Junior Resident |
| Affiliation |
Chirayu Medical College and Hospital |
| Address |
Department of Anaesthesiology
Chirayu Medical College and Hospital
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9754151325 |
| Fax |
|
| Email |
sagnikdattamajumdar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chirayu Medical College and Hospital, Bhopal |
|
|
Primary Sponsor
|
| Name |
CMCH, Bhopal |
| Address |
CMCH, Bhopal |
| Type of Sponsor |
Private 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 Sagnik Datta Majumdar |
Chirayu Medical College and Hospital |
3rd Floor
Department of Anaesthesiology
Chirayu Medical College and Hospital
Bhopal
MADHYA PRADESH |
9754151325
sagnikdattamajumdar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Chirayu Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pre-mixed Hyperbaric Bupivacaine and Fentanyl |
Pre-mixed mixture of Hyperbaric Bupivacaine and Fentanyl will be administred in this group. |
| Intervention |
Sequential Injection of Fentanyl with Hyperbaric Bupivacaine |
25 mcg of Fentanyl will be loaded in a 2 ml syringe and 15 mg of Hyperbaric Bupivacaine(0.5%) will be loaded in a 5 ml syringe. Fentanyl will be administered first followed by Bupivacaine at a rate of 0.2 ml per second in this method. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing lower abdominal surgery
American Society of Anaesthesiologits Grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients with history of opioid intake
Patients who refuse to participate in the study
Patients with known allergy to drugs used in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the onset and completion of sensory and motor blockade in both groups |
The sensory and motor blockade will be assessed continuously till the achievment of onset and completion of blockade (5-20 mins). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the hemodynamic effect, duration of block, requirement of rescue analgesia and adverse events in both groups |
Immedicately after the block and at every 1 minute interval for the first 5 minutes and then till 10 minutes |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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 Yet Recruiting |
| 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
|
Due to the limited duration of spinal anaesthesia, opioids have been added to local anaesthetics to increase the duration and improve the quality of spinal block. Fentanyl has been considered as the adjuvant of choice owing to its potency, fast onset, short duration of action and lower incidence of respiratory depression.This study is being done to compare the onset and completion of the block, hemodynamic profile, duration of block, rescue analgesia requirement and adverse events of sequential administration of intrathecal fentanyl and bupivacaine to the routine mixing of the two drugs in patients posted for lower abdominal surgeries under spinal anaesthesia. |