| CTRI Number |
CTRI/2026/02/103816 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
12/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of dexmedetomidine alone vs Dexmedetomidine combined with Ketamine for better blood pressure stability and pain control during spine surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparative evaluation of dexmedetomidine versus ketamine with dexmedetomidine on hemodynamic stability and analgesic efficiency in dorsolumbar spine surgery under general anaesthesia: a double-blinded 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 |
Dr Rishabh Kumar Singh |
| Designation |
JUNIOR RESIDENT Dept of Anesthesiology |
| Affiliation |
Heritage Institute of Medical Sciences |
| Address |
Heritage Institute of Medical Sciences , Dept of Anesthesiology , 4th floor,Room no-6, NH-2 By pass Bhadwar Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
8354955933 |
| Fax |
|
| Email |
rs0180444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Col Shyamal Maity |
| Designation |
Professor |
| Affiliation |
Heritage Institute of Medical Sciences |
| Address |
Heritage Institute of Medical Sciences , Dept of Anesthesiology , 4th floor,Room no-406, NH-2 By pass Bhadwar Varanasi Uttar Pradesh
NTS Building room no -702
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
7904635636 |
| Fax |
|
| Email |
shyamalmaity@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Col Shyamal Maity |
| Designation |
Professor |
| Affiliation |
Heritage Institute of Medical Sciences |
| Address |
Heritage Institute of Medical Sciences , Dept of Anesthesiology , 4th floor,Room no-406, NH-2 By pass Bhadwar Varanasi Uttar Pradesh
NTS Building room no -702
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
7904635636 |
| Fax |
|
| Email |
shyamalmaity@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Heritage Institute of Medical Sciences ,NH-2 ,By pass Bhadwar varanasi uttar pradesh -221311 |
|
|
Primary Sponsor
|
| Name |
Heritage Institute of Medical Sciences |
| Address |
Heritage Institute of Medical Sciences ,NH-2 ,By pass Bhadwar varanasi uttar pradesh -221311 |
| 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 Rishabh Kumar Singh |
Heritage Institute of Medical Sciences NH-2By pass bhadwar varanasi uttar pradesh |
Heritage Institute of Medical Sciences , Dept of Anesthesiology , 4th floor,OT NO-1Room neuro O.T.
Varanasi
UTTAR PRADESH |
08354955933
rs0180444@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee HIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine+ dexmedetomidine combinatin-
|
Ketamine will be administered intravenously as a bolus dose of 0.25 mg/kg at induction of anesthesia.
Dexmedetomidine will be administered intravenously as a loading dose of 0.5 µg/kg over 10 minutes before induction, followed by a continuous infusion of 0.25 µg/kg/hour intraoperatively.
Route: Intravenous
Frequency: Single bolus (ketamine) + loading dose and continuous infusion (dexmedetomidine)
Total duration: From induction of anesthesia till completion of surgery |
| Intervention |
Dexmedetomidine |
Dexmedetomidine will be administered intravenously as a loading dose of 1 µg/kg over 10 minutes before induction of anesthesia, followed by a continuous infusion of 0.5 µg/kg/hour intraoperatively.
Route: Intravenous
Frequency: Single loading dose followed by continuous infusion
Total duration: From induction of anesthesia till completion of surgery |
| Comparator Agent |
Routine general anesthesia with no additional drugs |
Routine general anesthesia with standard induction agents (fentanyl, propofol) and muscle relaxant (vecuronium) as per institutional protocol. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients posted for dorsolumbar spine surgery
|
|
| ExclusionCriteria |
| Details |
Patient with known allergy to study drugs
Pregnancy and lactating women.
Neurological disorder affecting pain perception.
Minimal invasive/Endoscopic spinal surgerys.
Patient with known Hypertension. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intra-operative hemodynamic stability, assessed by:
Heart rate (HR)
Systolic blood pressure (SBP)
Diastolic blood pressure (DBP)
Mean arterial pressure (MAP)
|
Baseline before induction of anesthesia
After Induction
Post-Intubation
after Positioning (Prone)
Every 15 min Intraoperatively
End of surgery
Post -Extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post-operative pain intensity, assessed using:
Visual Analog Scale (VAS) / Numerical Rating Scale (NRS) at fixed time intervals
Total post-operative analgesic/opioid requirement within the first 24 hours
Time to first rescue analgesia
Incidence of adverse effects, including:
Bradycardia
Hypotension
Nausea & vomiting |
Postoperative pain will be assessed using Visual Analogue Scale (VAS) at 0, 4, 8, 12, 16, 20 & 24 hours postoperatively.
Total rescue analgesic consumption will be recorded over the first 24 hours postoperatively.
Adverse effects (bradycardia, hypotension, nausea, vomiting, sedation) will be monitored intraoperatively & for 24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
23/02/2026 |
| 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="2"
Days="28" |
|
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
|
The present study is designed to compare the effects of dexmedetomidine alone and ketamine combined with dexmedetomidine in patients undergoing dorsolumbar spine surgery under genral anesthesia. Intraoperative hemodynamic stability will be assessed as the primary outcome, post operative pain scores and total analgesic requirment will be recorded to evaluate the overall analgesic effectiveness of both techniques. |