| CTRI Number |
CTRI/2023/12/060570 [Registered on: 20/12/2023] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between Fentanyl and Clonidine as an adjuvant to Ropivacaine heavy in spinal anaesthesia in lower abdominal surgeries |
|
Scientific Title of Study
|
A prospective study to access the efficacy of Clonidine and Fentanyl as adjuvants to Hyperbaric Ropivacaine in infra umbilical surgeries performed under spinal anaesthesia |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramavath Roop Singh |
| Designation |
Post graduate trainee MD Anaesthesia |
| Affiliation |
Midnapore medical College and hospital |
| Address |
Midnapore Medical College and Hospital, Department of anaesthesia and critical care, Paschim Medinipur, West Bengal,721101.
Medinipur
WEST BENGAL
721101
India |
| Phone |
8106697767 |
| Fax |
|
| Email |
ramavathroopsingh150@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asim Kumar Maiti |
| Designation |
Assistant professor department of anaesthesia |
| Affiliation |
Midnapore Medical College and hospital |
| Address |
Department of anaesthesia, Midnapore Medical College and hospital, Paschim Medinipur, West Bengal
Medinipur
WEST BENGAL
721101
India |
| Phone |
9233304769 |
| Fax |
|
| Email |
maitiasim1603@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asim Kumar Maiti |
| Designation |
Assistant professor department of anaesthesia |
| Affiliation |
Midnapore Medical College and hospital |
| Address |
Department of anaesthesia, Midnapore Medical College and hospital, Paschim Medinipur, West Bengal
WEST BENGAL
721101
India |
| Phone |
9233304769 |
| Fax |
|
| Email |
maitiasim1603@gmail.com |
|
|
Source of Monetary or Material Support
|
| Office of principal midnapore medical College and hospital |
|
|
Primary Sponsor
|
| Name |
Office of principal midnapore medical College and hospital |
| Address |
Midnapore Medical College and hospital, Paschim Medinipur, West Bengal,721101 |
| 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 |
| Ramavath Roop Singh |
General surgery operation theatre |
Midnapore Medical College and hospital, Department of anaesthesia and critical care, Paschim Medinipur, West Bengal
Medinipur
WEST BENGAL |
8106697767
ramavathroopsingh150@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Midnapore 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 |
Intrathecal clonidine as an adjuvant to hyperbaric ropivacaine in subarachnoid block for elective lower abdominal surgeries |
Intrathecal clonidine 30mcg along with 3.5ml of 0.75% hyperbaric ropivacaine in spinal anaesthesia for elective lower abdominal surgeries before starting of surgery |
| Intervention |
Intrathecal fentanyl as adjuvant to hyperbaric ropivacaine in subarachnoid block for elective lower abdominal surgeries |
Intrathecal fentanyl 25mcg along with 3.5ml of 0.75% hyperbaric ropivacaine in spinal anaesthesia for elective lower abdominal surgeries before starting of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1.ASA grade 1&2
2. Age group of 18-60 years
3. Body mass index between 18.5-24
4. Elective lower abdominal surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patients with severe cardio- respiratory disease
2. Patients with hepatic and renal disease
3. Patients with neurological disorders
4. Patients with endocrine disorders
5. Subarachnoid block failure
6. Convertion to general anaesthesia
7. Patients with psychiatric problem
8. Any contraindications for spinal anaesthesia
9. Drug allergy to study drug |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing block characteristics in respect to sensory block, motor block and duration of post operative analgesia |
before spinal, after spinal, at 5,10,15,20,25,30,40,50,60,70, 80,90 min after spinal or till completion of surgery and 2hr, 4hr, 10hr, 14hr,18hr, 22hrs, 24 hrs post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Highest level of sensory block
2. quality of motor block
3. requirement of rescue analgesia
4. hemodynamic parameters like Mean blood pressure, systolic blood pressure, diastolic blood pressure, heart rate, spo2, respiratory rate
5. evaluation of opioid related adverse effects if any |
before spinal, after spinal, at 5,10,15,20,25,30,40,50,60,70, 80,90 min after spinal or till completion of surgery & 2hr, 4hr, 10hr, 14hr,18hr, 22hrs, 24 hrs post op |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/01/2024 |
| 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
|
No publication yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparison between intrathecal fentanyl and clonidine as adjuvants to hyperbaric ropivacaine in subarachnoid block for elective lower abdominal surgeries under spinal anaesthesia: A prospective, randomised, double blinded, comparative study.To compare the duration of motor and sensory block of intrathecal 25mcg fentanyl and intrathecal 30mcg clonidine along with 0.75% hyperbaric ropivacaine.
To compare the post operative analgesia in patients given intrathecal fentanyl and intrathecal clonidine.
To compare the side effects and complications (if any) of the given drug during intraoperative and post operative period.
This is a hospital based, prospective, randomised, double blinded, comparative analytical study on cohort of patients posted for elective lower abdominal surgeries under subarachnoid block in general surgery operation theatre Midnapore Medical College and hospital.
As we are using equipotent dose of fentanyl and clonidine and both increases duration of block and postoperative analgesia we expect both the group receiving fentanyl and clonidine will have a longer duration of block and postoperative analgesia but among both the groups which one will provide longer duration of block and postoperative analgesia will be known after completion of the. study
|