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CTRI Number  CTRI/2025/06/089817 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 28/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to determine the efficacy of Dexmeditomidine vs Dexmeditomidine with Ketamine in management of postoperative pain in spinal surgery patients 
Scientific Title of Study   A Comparative Study Of Demedetomidine - Ketamine Infusion Vs Dexmedetomidine Infusion For Post Operative Analgesia In Spine Surgeries A Prospective Double Blinded Randomised Control Trail.  
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 G yoshitha 
Designation  Post Graduate 
Affiliation  sri balaji vidyapeeth 
Address  Department of Anaesthesia ,Shri Sathya Sai medical collage and research institue .Thiruporur, Guduvancherry main road,chengalpattu taluk, Kanchipuram district ,Tamil nadu

Kancheepuram
TAMIL NADU
603108
India 
Phone  9080130368  
Fax    
Email  yoshigsr.reddy1992@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dilip kumarG 
Designation  Professor,Head of the department 
Affiliation  sri balaji vidyapeeth 
Address  Department of Anaesthesia ,Shri Sathya Sai medical collage and research institue .Thiruporur, Guduvancherry main road,chengalpattu taluk, Kanchipuram district ,Tamil nadu

Kancheepuram
TAMIL NADU
603108
India 
Phone  9094940243  
Fax    
Email  dilipko@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr G yoshitha 
Designation  Post graduate 
Affiliation  sri balaji vidyapeeth 
Address  Department of Anaesthesia ,Shri Sathya Sai medical collage and research institue .Thiruporur, Guduvancherry main road,chengalpattu taluk, Kanchipuram district ,Tamil nadu
reddy street
Kancheepuram
TAMIL NADU
603108
India 
Phone  09080130368  
Fax    
Email  yoshigsr.reddy1992@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  G Yoshitha 
Address  Department of Anaesthesiology Shri Sathya Sai Medical College and Research institue Thiruporur Guduvancherry Main Road chengalpattu taluk Kanchipuram district Tamil Nadu  
Type of Sponsor  Other [Self] 
 
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 
DrG Yoshitha  Shri Sathya Sai medical collage and research institue   Shri Sathya Sai Medical College and Research institue Thiruporur Guduvancherry Main Road chengalpattu taluk Kanchipuram district Tamil Nadu
Kancheepuram
TAMIL NADU 		 9080130368

yoshigsr.reddy1992@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Human Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M469||Unspecified inflammatory spondylopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexmedetomedine infusion  dexmed (1 mcg/kg) followed by propofol 2 (mg/kg) and maintained with dexmedetomidine infusion at 0.3 mcg/kg/hr 
Comparator Agent  dexmedetomidine and ketamine  1 mg/kg of ketamine and 1 mcg/kg of dexmedetomidine over 10 minutes and propofol (1 mg/kg) maintained at 0.25 mg/kg/hr of ketamine and 0.3 mcg/kg/hr of dexmedetomidine 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients assesed and physically fit under the ASA category 1 and 2 
 
ExclusionCriteria 
Details  Patients with sensory deficits at the level planned for surgery.
● Patients with Severe hypertension/coronary artery disease/heart block/psychiatric illness
Patients with Liver / renal disease
Patients with the raised intracranial pressure
Patients on Alpha-2agonists or beta blockers
Patients belonging to American society of Anaesthesiologists(ASA)Physical status ¾ 
 
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 
visual analogue score   24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the pain scores & hemodynamic parameters & side effects of drugs  intraoperative & postoperative 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   11/07/2025 
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  
After getting approval from the ethics committee, patients will be randomly allocated into 2 groups
via computer generated group of numbers.


Group A: Patients in group KD will be induced with ketodex (1 mg/kg of ketamine and 1 μg/kg of dexmedetomidine over 10 minutes) and propofol (1 mg/kg) and maintained with low-dose ketodex infusion (0.25 mg/kg/hr of ketamine and 0.3 μg/kg/hr of dexmedetomidine), O2/N2O, and Sevoflurane. Ketamine and dexmedetomidine will be administered simultaneously via two separate infusion pumps.


Group B:Patients in group D will be induced with dexmed (1 mcg/kg) followed by propofol 2 (mg/kg) and maintained with dexmedetomidine infusion (0.3 μg/kg/hr), O2/N2O, and sevoflurane. The patient will be intubated 4 minutes after administering vecuronium (0.1 mg/kg) when the TOF was zero. The patients will be positioned prone as per the planned procedure and the surgeon’s need.
 
Heart rate (HR), BP, ECG, SpO2, end-tidal carbon dioxide, BIS, TOF parameters, and temperature will be monitored intraoperatively. Intraoperative anesthesia will be maintained using sevoflurane in O2/N2O (1:1 mixture) to maintain a BIS of 40–60, and administration of vecuronium top-up (0.02 mg/kg) will be guided by the TOF. If BIS will be >60 and HR will be >20% of baseline, the sevoflurane concentration will be increased. If HR is >20% of baseline and the BIS is 40–60, 0.3 mcg/kg of Dexmedetomidine will be injected and the dose will be recorded. No additional non-opioid analgesics will be administered intraoperatively in either group.
 
 
The infusions will be continued until the application of the last skin suture. At this timepoint, the maintenance anaesthetic agent sevoflurane will be stopped. The residual neuromuscular blockade will be reversed with an injection of neostigmine (50 μg/kg) and glycopyrrolate (10 μg/kg) based on the TOF ratio of ≥0.6 and count of 4 and when the patient’s spontaneous breathing will be resumed. Before extubation, the anti-emetic agent ondansetron (0.1 mg/kg) will be administered. After extubation, the patients will be shifted to the post-anaesthesia care unit (PACU) for further monitoring.


Postoperatively, all patients will be administered injectable diclofenac (1.5 mg/kg) every 8 hours and the NRS scores will be recorded every 4 hours for 24 hours. An NRS score of 4 will be set as the threshold for tolerable postoperative pain. In patients complaining of intolerable pain (NRS >4), rescue analgesia will be administered {1 mcg/kg intravenous Fentanyl}. The time to the first rescue analgesia dose and perioperative analgesic requirements will be recorded and compared among the groups. “Postoperative opioid requirements” will be defined as the total rescue analgesic bolus doses administered in 24 hours.

The primary objective of the current study is to compare the postoperative opioid requirement for the first 24 hours after administration of intraoperative low-dose ketodex and dexmedetomidine infusion in patients undergoing thoracolumbar spine surgery. The secondary objectives is to compare the intraoperative anaesthetic requirements, postoperative pain scores, hemodynamic parameters, any side effects of study drugs and the duration of PACU stay among groups.
 
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