| CTRI Number |
CTRI/2023/03/051196 [Registered on: 31/03/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of intrathecal clonidine and dexmedetomidine added with bupivacaine for post-operative analgesia in gynaecological surgeries. |
|
Scientific Title of Study
|
A comparative clinical study of intrathecal clonidine and dexmedetomidine added with bupivacaine for post-operative analgesia in gynaecological surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YOGITA SORTE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF ANAESTHESIA, PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE.
DEPARTMENT OF ANAESTHESIA, PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE.
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9806179234 |
| Fax |
|
| Email |
yogitanimje84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
YOGITA SORTE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF ANAESTHESIA, PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE.
DEPARTMENT OF ANAESTHESIA, PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE.
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9806179234 |
| Fax |
|
| Email |
yogitanimje84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
YOGITA SORTE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF ANAESTHESIA, PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE.
DEPARTMENT OF ANAESTHESIA, PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE.
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9806179234 |
| Fax |
|
| Email |
yogitanimje84@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIA, PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE. |
|
|
Primary Sponsor
|
| Name |
DR. YOGITA SORTE |
| Address |
DEPARTMENT OF ANAESTHESIA, PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE. |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR YOGITA SORTE |
PEOLPES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
DEPARTMENT OF ANAESTHESIA, PEOLPES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE, BHOPAL
Bhopal
MADHYA PRADESH |
9806179234
yogitanimje84@gmail.com |
| DR YOGITA SORTE |
PEOLPES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
DEPARTMENT OF ANAESTHESIA
Bhopal
MADHYA PRADESH |
9806179234
yogitanimje84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
Approved |
| PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
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 |
HYPERBARIC BUPIVACAINE (0.5%) 15 MILIGRAM PLUS CLONIDINE 30 MICROGRAM. |
Sabarachnoid block with hyperbaric bupivaicaine with adjuvant clonidine in one group and dexmedetomidine in another group will be given in gynaecological surgery. |
| Comparator Agent |
HYPERBARIC BUPIVACAINE (0.5%) 15 MILIGRAM PLUS DEXMEDETOMIDINE 10 MICROGRAM. |
Sabarachnoid block with hyperbaric bupivaicaine with adjuvant clonidine in one group and dexmedetomidine in another group will be given in gynaecological surgery. |
| Intervention |
SABARACHNOID BLOCK |
Sabarachnoid block with hyperbaric bupivaicaine with adjuvant clonidine in one group and dexmedetomidine in another group will be given in gynaecological surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Informed written consent for participation in study.
2.Patients posted for gynaecological surgeries.
3.ASA physical status I and II. |
|
| ExclusionCriteria |
| Details |
Contraindication to subarachnoid block.
Allergy to local anaesthetic or study drug.
Uncontrolled or labile hypertension.
Patients taking any analgesics, sedative or antihypertensive drugs.
Neurological disorders.
Psychiatric disorders.
Uncooperative patients. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO STUDY AND COMPARE THE ONSET OF ANALGESIA, DURATION OF MOTOR BLOCKADE, DURATION OF SENSORY BLOCKADE, HAEMODYNAMIC PARAMETERS OF INTRATHECAL CLONIDINE AND DEXMEDETOMIDINE ADDED WITH BUPIVACAINE. |
TO STUDY AND COMPARE THE ONSET OF ANALGESIA, DURATION OF MOTOR BLOCKADE, DURATION OF SENSORY BLOCKADE, HAEMODYNAMIC PARAMETERS OF INTRATHECAL CLONIDINE AND DEXMEDETOMIDINE ADDED WITH BUPIVACAINE. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO STUDY AND COMPARE THE ONSET OF ANALGESIA, DURATION OF MOTOR BLOCKADE, DURATION OF SENSORY BLOCKADE, HAEMODYNAMIC PARAMETERS OF INTRATHECAL CLONIDINE AND DEXMEDETOMIDINE ADDED WITH BUPIVACAINE. |
TO STUDY AND COMPARE THE ONSET OF ANALGESIA, DURATION OF MOTOR BLOCKADE, DURATION OF SENSORY BLOCKADE, HAEMODYNAMIC PARAMETERS OF INTRATHECAL CLONIDINE AND DEXMEDETOMIDINE ADDED WITH BUPIVACAINE. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NO YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
VARIOUS CLINICAL STUDY HAVE FOUND THAT ADMINISTRATION OF INTRATHECAL CLONIDINE AND DEXMEDETOMIDINE ADDED WITH BUPIVACAINE PROLONGS THE DURATION OF SENSORY AND MOTOR BLOCKADE AS WELL AS DURATION OF ANALGESIA. HOWEVER THESE ARE LIMITED DATA AVAILABLE ON COMPARING INTRATHECAL CLONIDINE AND DEXMEDETOMIDINE ADDED WITH BUPIVACAINE. |