| CTRI Number |
CTRI/2025/09/094822 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between dexmedetomidine and clonidine on sensory and motor responses and sedation |
|
Scientific Title of Study
|
A comparative study to evaluate effects of intravenous dexmedetomidine versus clonidine on extent and duration of subarachnoid block in 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 Vishawdeep Joshi |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesia Shri Ram Murthy Smarak Institute of Medical Sciences (SRMSIMS) |
| Address |
Department of Anaesthesia
Shri Ram Murthy Smarak Institute of Medical Sciences (SRMSIMS)
UTTAR PRADESH
Bareilly – 243202
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
08264677216 |
| Fax |
|
| Email |
vishavjoshi23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Juhi Saran |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesia Shri Ram Murthy Smarak Institute of Medical Sciences (SRMSIMS) . |
| Address |
Department of Anaesthesia
Shri Ram Murthy Smarak Institute of Medical Sciences (SRMSIMS).
Bareilly – 243202
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
931951711 |
| Fax |
0581-2582030 |
| Email |
deepanvitasaran16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Akhilesh Pahade |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anaesthesia Shri Ram Murthy Smarak Institute of Medical Sciences (SRMSIMS) . |
| Address |
Department of Anaesthesia
Shri Ram Murthy Smarak Institute of Medical Sciences (SRMSIMS)
Bareilly – 243202
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9818128778 |
| Fax |
|
| Email |
akhileshpahade09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
Shri Ram Murthy Smarak Institute of Medical Sciences (SRMSIMS)
Bhojipura, Bareilly – 243202 |
|
|
Primary Sponsor
|
| Name |
SRMSIMS |
| Address |
Ram Murti Puram,13KM,Barielly-Nainital Rd ,BhojiPura,Abheypur Keshonpur,Uttar Pradesh,243202 |
| 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 Vishawdeep joshi |
OT Complex,Department of Anaesthesia Shri Ram Murthy Smarak Institute of Medical Sciences |
Department of Anaesthesia
Shri Ram Murthy Smarak Institute of Medical Sciences (SRMSIMS)
Bhojipura, Bareilly – 243202
Bareilly
UTTAR PRADESH |
8264677216
vishavjoshi23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ELECTIVE SURGERIES FOR ASA GRADE 1 AND 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous clonidine(1 microgram/kg) |
54 patients receiving 1 microgram dose of intravenous clonidine diluted into 100ml normal saline given prior to subarachnoid block |
| Intervention |
Intravenous dexmedetomidine(0.5 microgram/kg) |
54 Patients receiving 0.5 microgram dose of intravenous dexmedetomidine diluted into 100ml normal saline given iv just prior to subarachnoid block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-60 years of either sex with ASA physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
ASA Grade 3 and 4
2) Unwillingness to be a part of the trial or patient refusal
3) Allergytothestudydrugs
4) Age less than 18 years and more than 60 years
5) History of major trauma to spine or History of nuerodegenerative diaorders
6) Uncontrolled Diabetes mellitus/ Hypertension
7 Systemicillnessesinvolvingcardiovascular,nervousorrespiratorysystem,anyrenalorliverd
isease
8) Hemodynamically unstable patient
9) Pregnancy
10)Patients with known spinal deformities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effect of different doses of dexmedetomidine and clonidine as
adjunct agent on hemodynamics in patients undergoing elective surgical procedures
under regionalanaesthesia.
2. To evaluate the effect of three different doses of ketamine-propofol combination as
inductionagentonrecoveryprofileofpatientsundergoingelectivesurgicalprocedures under
generalanaesthesia. |
Haemodynamic variables such as heart rate (HR), systolic blood pressure (SBP),
diastolic bloodpressure (DBP) and mean arterial blood pressure (MABP) will be
monitored at baseline (Prior to intravenous injection), immediately post injection and upto 120 minutes(3,6,10,15,30,45,60,75,90,105,120minutes) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the evaluation of different doses of dexmedtomidine & Clonidine as an
adjuvant on hemodynamic & recovery profile in patients undergoing elective
surgicalprocedures under regional anaesthesia.
To check sideeffects of both the drugs in patients undergoing elective surgical procedures
under regional anaesthesia |
PONV,vomiting,headache & tachycardia to be assesed after immediate end of surgery to hourly upto 6 hours(1,2,3,4,5,6hours respectively) |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
30/09/2025 |
| 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
|
Subarachnoid block is widely used for infraumbilical surgeries but is often limited by shorter duration of blockade and less postoperative analgesia.Alpha2 adrenergic agonist such as clonidine and dexmedetomidine when given intravenously enhance block duration ,provide stable haemodynamics and better postoperative analgesia.Clonidine ,a partial alpha 2 agonist and dexmedetomidine a more selective agent differ in potency and clinical profile.This study compares iv clonidine and iv dexmedetomidine as adjuncts to subarachnoid block(motor and sensory),..focusing on extent,duration and postoperative analgesia and haemodynamic stability to establish more effective agent for infraumbilical surgeries |