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CTRI Number  CTRI/2026/02/103750 [Registered on: 12/02/2026] Trial Registered Prospectively
Last Modified On: 11/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   This study looks at how a combination of two medicines (dexmedetomidine and ketamine) helps reduce pain after surgery in patients having lower-abdomen below the belly button operations, where only the lower part of the body is numb 
Scientific Title of Study   Effect of dexmedetomidine plus ketamine on postoperative analgesia in patients undergoing infra umbilical surgeries under spinal anaesthesia 
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 Preeti Gehlaut 
Designation  Professor 
Affiliation  PGIMS Rohtak 
Address  Department of Anaesthesiology & Critical Care, Pt. B. D. Sharma PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  8950285434  
Fax    
Email  Preeti.gehlaut@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjiv Kumar 
Designation  Junior resident 
Affiliation  PGI Rohtak 
Address  Department, Department of anaesthesia and critical care, PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  8529762976  
Fax    
Email  Sanjivpanchal906@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjiv Kumar 
Designation  Junior resident 
Affiliation  PGI Rohtak 
Address  Department, Department of anaesthesia and critical care, PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  8529762976  
Fax    
Email  Sanjivpanchal906@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Pandit B.D Sharma PGIMS Rohtak 
Address  Pandit B.D Sharma, PGIMS Rohtak, Haryana, 124001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sanjiv kumar  Pandit BD Sharma, PGIMS Rohtak   Department of anaesthesiology and critical care, modular OT cum ICU Complex
Rohtak
HARYANA 		 8529762976

sanjivpanchal476@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics committee, PGIMS, ROHTAK   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection dexmedetomidine plus ketamine infusion  patients will a receive loading dose of injection dexmedetomidine (drug 1) 0.5mcg/kg and injection ketamine (drug 2) 0.3 mg/kg, slowly over 10 minutes. Thereafter, at 0.3mcg/kg/hr and 0.2 mg/kg/hr Edit Il Delete respectively, till last suture is placed. 
Comparator Agent  Placebo given in form of normal saline. patients will receive normal saline (NS) in similar manner via infusion in 2 different syringes, labelled as drug 1 and drug 2.  NS labelled as drug 1 at 0.5mcg/kg and NS labelled as drug 2 at 0.3 mg/kg, slowly over 10 minutes. Thereafter, at 0.3mcg/kg/hr and 0.2 mg/kg/hr respectively, till last suture is placed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients age 18 to 65 years of either sex belonging to ASA physical status 1/2 scheduled for infra umbilical abdominal surgery under subarachnoid block 
 
ExclusionCriteria 
Details  Refusal to participate.
Contraindication to spinal anaesthesia
Ischemic heart disease
recent head injury or neuro psychiatric illness
Known allergy to the drugs being used
Pregnancy
Surgery duration, less than one hour
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effect of dexmedetomidine plus ketamine infusion on duration of analgesia, post-operative pain score and rescue analgesia requirement  0mins, 5mins , 10mins , 15mins , 20mins , 25mins , 30mins , 40mins, 50mins,60mins, 70mins , 80mins, 90mins, 100mins , 110mins , 120mins, in post operative period  
 
Secondary Outcome  
Outcome  TimePoints 
Changes in haemodynamic parameters.  30mins , 1hr, 2hr, 6hrs, 12hrs , 24hrs 
Ramsay sedation scores  15mins , 30mins , 45mins ,60mins, 75mins , 90mins , 105mins , 120mins, 135mins, 150mins, in post operative period  
Patient satisfaction  24hrs post operative period  
Complications, if any: Hypotension, Bradycardia, Shivering, Nausea and vomiting,
hallucinations, Nightmares/vivid dreams, visual disturbances (nystagmus, blurred vision) 		 At any given point of time in post operative period till 24hrs 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   16/03/2026 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sanjivpanchal476@gmail.com].

  6. For how long will this data be available start date provided 31-01-2026 and end date provided 31-03-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study evaluates the effect of intravenous dexmedetomidine combined with ketamine on postoperative analgesia in patients undergoing infraumbilical surgeries under spinal anaesthesia. Spinal anaesthesia has limited duration, and commonly used intrathecal adjuvants have notable side effects. Dexmedetomidine and ketamine, when used together, may provide synergistic analgesia with better haemodynamic stability. This prospective, randomized, double-blind, placebo-controlled study includes 80 ASA I–II patients aged 18–65 years. Primary outcomes include duration of analgesia, postoperative pain scores, and rescue analgesic requirement, while secondary outcomes assess haemodynamics, sedation, patient satisfaction, and complications. 
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