| CTRI Number |
CTRI/2025/07/090145 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of two different drugs as an additional agent to epidural drug on duration of pain relief after surgery in lower abdominal surgeries. |
Scientific Title of Study
Modification(s)
|
Comparison of the Effect of Dexmedetomidine and Clonidine as an Adjuvant to Epidural Levobupivacaine on Duration of Post-Operative Analgesia in Total Abdominal Hysterectomy-A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahesh kumar M |
| Designation |
post graduate |
| Affiliation |
SRM medical college and research centre |
| Address |
Room No. 209, B-Block, 2nd Floor, Dept of Anaesthesiology, SRM medical college hospital and research centre , kattankulathur campus , chengalpattu 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9791196482 |
| Fax |
|
| Email |
muruganmahesh97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Balaji R |
| Designation |
Professor MD anesthesia |
| Affiliation |
SRM medical college and research centre |
| Address |
Room No. 209, B-Block, 2nd Floor, Dept of Anaesthesiology, SRM medical college hospital and research centre , kattankulathur campus , chengalpattu 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9677053310 |
| Fax |
|
| Email |
aarbee79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahesh kumar M |
| Designation |
post graduate MD anesthesia |
| Affiliation |
SRM medical college and research centre |
| Address |
Room No. 209, B-Block, 2nd Floor, Dept of Anaesthesiology, SRM medical college hospital and research centre , kattankulathur campus , chengalpattu 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9791196482 |
| Fax |
|
| Email |
muruganmahesh97@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SRM medical college hospital and research centre |
| Address |
SRM medical college hospital research centre , kattankulathur campus , chengalpattu 603203 |
| 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 |
| Mahesh kumar M |
SRM medical college hospital and research centre |
Room No. 209, B-Block, 2nd Floor, Dept of Anaesthesiology, SRM medical college hospital and research centre , kattankulathur campus , chengalpattu 603203
Kancheepuram
TAMIL NADU |
9791196482
muruganmahesh97@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N950||Postmenopausal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
post operative epidural analgesia |
effect of clonidine at 1 microgram per kilogram in epidural drug of 0.5% levobupivacaine 15 ml to check post operative analgesia |
| Intervention |
post operative epidural analgesia |
effect of dexmeditomidine at 1 microgram per kilogram dose along with epidural drug of 0.5% Levobupivacaine 15ml in epidural to check post operative analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
2. American society of anesthesiologist physicial status grade I , grade II and grade III |
|
| ExclusionCriteria |
| Details |
1.Sepsis and Coagulopathy
2. Uncorrected hypovolemia
3. Elevated ICP , infection in localized site and neurological disease
4. Preexisting liver disease, renal disease , cardiac disease
5. BMI >30 kg/m^2
6. Surgeries lasting more than two hours. |
|
|
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 |
| To compare the duration of post operative analgesia |
0-24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| motor blockade |
5 mins for the first half hour followed by every 10 minutes for two hours |
| sensory blockade |
every minute |
| modified bromage scale |
every 5 minutes for first 15 minutes |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
07/07/2025 |
| 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="6"
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
|
Epidural anesthesia using long-acting local anesthetics is safe, familiar, and inexpensive technique, and it also provides postoperative analgesia. Quality and duration of analgesia is improved when local anesthetic is combined with alpha 2 adrenergic agonist. No studies seen on the effect of dexmedetomidine and clonidine as adjuvant to epidural levobupivacaine previously. We hypothesise that Dexmedetomidine prolongs the duration of post operative analgesia better than clonidine when used as an adjuvant to levobupivacaine in epidural analgesia |