| CTRI Number |
CTRI/2026/04/108048 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
03/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY COMPARING TWO DRUGS DEXMEDETOMIDINE AND CLONIDINE AS ADJUVANTS TO INTRATHECAL 0.5 PERCENT HYPERBARIC BUPIVACAINE IN INFRAUMBILICAL SURGERIES |
|
Scientific Title of Study
|
COMPARISON OF DEXMEDETOMIDINE VERSUS CLONIDINE AS AN ADJUVANT TO INTRATHECAL 0.5 PERCENT HYPERBARIC BUPIVACAINE HEAVY IN INFRAUMBILICAL SURGERIES, A PROSPECTIVE RANDOMIZED DOUBLE BLIND STUDY |
| 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 Honey Agarwal |
| Designation |
Resident Anesthesiology |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care Third Floor Pacific Medical College and Hospital
Udaipur
RAJASTHAN
313001
India |
| Phone |
7021078062 |
| Fax |
|
| Email |
honeyagarwal028@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Chandra Audichya |
| Designation |
Head of Department |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care Third Floor Pacific Medical College and Hospital
Udaipur
RAJASTHAN
313001
India |
| Phone |
9929721889 |
| Fax |
|
| Email |
prakash.audichya10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakash Chandra Audichya |
| Designation |
Head of Department |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care Third Floor Pacific Medical College and Hospital
Udaipur
RAJASTHAN
313001
India |
| Phone |
9929721889 |
| Fax |
|
| Email |
prakash.audichya10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care, Third Floor , Pacific Medical Colleg e and Hospital, Udaipur, Rajasthan Pincode 313001 |
|
|
Primary Sponsor
|
| Name |
Pacific Medical College and Hospital, Udaipur |
| Address |
Department of Anaesthesiology and Critical Care, Third Floor, Pacific Medical College and Hospital, Bhilo Ka Bedla Udaipur Rajasthan Pincode 313001 |
| 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 Honey Agarwal |
Pacific Medical College and Hospital |
Department of Anaesthesiology and Critical Care, Third Floor, Pacific Medical College and Hospital, Bilo Ka Bedla, Udaipur, Rajasthan Pincode 313001
Udaipur
RAJASTHAN |
7021078062
honeyagarwal028@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Commitee Pacific Medical College and Hospital Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (2) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (3) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, (4) ICD-10 Condition: N819||Female genital prolapse, unspecified, (5) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (6) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip, (7) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, (8) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection 0.5% Hyperbaric Bupivacaine + Clonidine (Intrathecal) |
Injection 0.5% hyperbaric Bupivacaine 15 mg combined with clonidine 15 mcg administered intrathecally at L3–L4 or L4–L5 interspace under strict aseptic precaution |
| Comparator Agent |
Injection 0.5% Hyperbaric Bupivacaine + Dexmedetomidine (Intrathecal) |
Injection 0.5% hyperbaric bupivacaine 15 mg combined with dexmedetomidine 10 mcg administered intrathecally at L3–L4 or L4–L5 interspace under strict aseptic precautionsI |
| Intervention |
Injection 0.5% Hyperbaric bupivacaine 15 mg |
Injection 0.5% hyperbaric Bupivacaine 15 mg administered intrathecally at L3–L4 or L4–L5 interspace under strict aseptic precautions |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of either sex of age group 18-60 year
ASA physical status I and II
Patient posted for elective infraumblical surgeries
Patient giving valid written and informed consent |
|
| ExclusionCriteria |
| Details |
Patient giving negative consent
PPatient with contraindication to spinal anaesthesia
Allergy to either drug used in the study
Patient posted for emergency surgery
|
|
|
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 onset , duration of sensory and motor block and post operative analgesia |
24 Hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study hemodynamic parameter and side effect if any |
24 Hrs |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/04/2026 |
| 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 Applicable |
| 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
|
Prospective , Randomized , Double Blind Study Comparing Intrathecal Dexmedetomidine Versus Clonidine as Adjuvant to 0.5% Hyperbaric Bupivacaine in Patients Undergoing Infraumblical Surgeries with Respect to Onset and Duration of Sensory and Motor Block , Post Operative Analgesia and Hemodynamic Stability |