| CTRI Number |
CTRI/2024/02/063093 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing duration of two drugs clonidine and fentanyl along with bupivacaine for anaesthesia |
|
Scientific Title of Study
|
Comparison of effects of clonidine versus fentanyl as adjuvant to intrathecal hyperbaric bupivacaine for elective infraumbilical 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 |
Dr Santhosh M C B |
| Designation |
Associate professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9886811263 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhosh M C B |
| Designation |
Associate professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya
KARNATAKA
571401
India |
| Phone |
9886811263 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santhosh M C B |
| Designation |
Associate professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya
KARNATAKA
571401
India |
| Phone |
9886811263 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya Institute of Medical sciences |
|
|
Primary Sponsor
|
| Name |
Dr Santhosh M C B |
| Address |
Associate professor
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr MD Mohsin Ahmed |
Post graduate student
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr MD Mohsin Ahmed |
Mandya Institute of Medical sciences |
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya
Mandya
KARNATAKA |
9844914378
mohsin.m2n@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee |
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 |
Clonidine |
Clonidine is a selective alpha 2 agonist which is known to increase both sensory and motor blocks of local anaesthetics intrathecally |
| Comparator Agent |
Fenatnyl |
Fenatnyl is a synthetic opioid and is a strong agonist at mu receptor and is preferred intrathecally because of its rapid onset |
| Intervention |
Spinal anaesthesia with hyperbaric bupivacaine with adjuvants |
Cases undergoing elective infraumbilical surgeries with spinal anaesthesia will be given either hyperbaric bupivacaine with fentanyl or hyperbaric bupivacaine with clonidine
Total duration is 12 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II
Patients willing to give informed consent to participate |
|
| ExclusionCriteria |
| Details |
Patients allergic to study anaesthetic drugs
Patients shorter than 150cm and taller than 180cm height
Patients with BMI more than 25kg per square meter
Patients on long term treatment with any opioids for chronic pain
Patients taking alpha receptor antagonists Calcium channel blockers Angiotension converting enzyme inhibitors or any any kind of analgesics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the sensory and motor characterstics between fentanyl and clonidine as adjuvant to intrathecal hyperbaric bupivacaine for infraumbilical surgeries |
12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare cardiorespiratory changes and adverse events between the groups |
12 hours |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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
|
This study has been designed to compare the effects of hyperbaric bupivacaine with low dose clonidine i.e., 15mcg versus hyperbaric bupivacaine with 25mcg fentanyl for spinal anaesthesia in patients undergoing infraumbilical surgeries. |