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CTRI Number  CTRI/2025/09/095442 [Registered on: 29/09/2025] Trial Registered Prospectively
Last Modified On: 28/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of ketamine infusion on fentanyl consumption in patients undergoing lumbar fixation surgery. 
Scientific Title of Study   Assessment of Effect of Ketamine on intraoperative opioid consumption in Patients undergoing Lumbar Fixation Surgery using Surgical Pleth Index: A 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 Neetu Jain 
Designation  Senior Consultant 
Affiliation  Sir Ganga Ram Hospital, New Delhi 
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram hospital, New Delhi-110060,INDIA

Central
DELHI
110060
India 
Phone  9871110160  
Fax    
Email  drneetujain@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neetu Jain 
Designation  Senior Consultant 
Affiliation  Sir Ganga Ram Hospital, New Delhi 
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram hospital, New Delhi-110060,INDIA

Central
DELHI
110060
India 
Phone  9871110160  
Fax    
Email  drneetujain@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Partiksha Jakhar 
Designation  Post Diploma DNB Trainee 
Affiliation  Sir Ganga Ram Hospital, New Delhi 
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram hospital, New Delhi-110060,INDIA

Central
DELHI
110060
India 
Phone  8168559185  
Fax    
Email  partikshajakhar@gmail.com  
 
Source of Monetary or Material Support  
Sir Ganga Ram Hospital, New Delhi 
 
Primary Sponsor  
Name  Sir Ganga Ram Hospital, New Delhi 
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, 5th Floor SSRB Block D, SGRH, Old Rajinder Nagar, Delhi 110060 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Neetu Jain  Sir Ganga Ram Hospital  OT 19, 7th Floor SSRB Block D, Sir Ganga Ram Hospital, Old Rajinder Nagar, Delhi 110060
Central
DELHI 
9871110160

drneetujain@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, SGRH  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 
Comparator Agent  0.9% Normal saline  0.9% normal saline infusion during surgery to see intraoperative fentanyl consumption in lumbar fixation surgery. 
Intervention  Ketamine  Ketamine infusion during surgery to see intraoperative fentanyl consumption in lumbar fixation surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Males or Females
2. Age: 18-75 years
3. ASA physical status I-II (American Society of Anaesthesiology) 
 
ExclusionCriteria 
Details  1. Patients with cardiac rhythm disorders, pacemakers, sympathetic nerve stimulators, vagus nerve stimulators.
2. Patients who underwent sympathectomy, vagotomy.
3. Patients on anti depressant, anti-anxiety, anticonvulsant and anti-parkinsonian drugs.
4. Known alcohol/ substance abuse.
5. Failure to obtain consent. 
 
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 
Cumulative fentanyl consumption  intraoperatively every 15 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Recovery time  From skin closure to tracheal extubation 
Post operative pain scores and requirement of rescue analgesia  At 30 min, 2hr, 6hr, 12hr and 24hr after surgery 
Post operative nausea and vomiting  At 30min, 2hr, 6hr, 12hr and 24 hr after surgery 
 
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   Phase 4 
Date of First Enrollment (India)   27/10/2025 
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="0"
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  

Lumbar fixation surgery is associated with significant pain, necessitating effective analgesic strategies. Opioids are used routinely for perioperative pain management; however, their use is limited by dose related side effects. Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist, possess analgesic properties and reduces opioid requirements, but its analgesic effects have not been assessed objectively in lumbar fixation surgery.

Assessment of pain during intraoperative period is often challenging as patients are unable to communicate pain intensity under general anaesthesia. Hence, surrogate markers are required. Noxious stimulation activates sympathetic system, resulting in tachycardia and vasoconstriction. These changes can be detected through pulse oximetry based plethysmography. Surgical pleth index (SPI) is a validated, non invasive tool that quantifies nociception by analyzing Pulse Plethysmographic amplitude (PPGA) and heart rate, thereby providing an indirect measure of sympathetic activity.

This proposed randomized controlled trial will include 60 patients undergoing single level lumbar fixation surgery, aimed at comparing the analgesic effect of ketamine in terms of  reduction in intraoperative opioid consumption as compared to placebo under general anaesthesia using SPI as an objective tool.

General anaesthesia will be induced and maintained using standard guidelines. Just before induction of anaesthesia, patient will be randomized into two groups. The intervention group will receive 0.5 mg/kg of Ketamine hydrochloride intravenously at induction followed by infusion of 0.2 mg/kg/hr and the placebo group will receive 0.9% normal saline of same volume and colour at same rate. Fentanyl supplementation will be guided by SPI values intraoperatively; whenever SPI rises above 50 for 1 minute, a bolus of fentanyl (0.5 mcg/kg) will be given. Additional fentanyl bolus will be given if SPI persists above 50 for five minutes. Maximum allowed cumulative fentanyl dose will be upto 20 mcg/kg. Intraoperative cumulative fentanyl consumption, recovery time, postoperative pain scores, rescue analgesia requirement and post operative nausea and vomiting (PONV) will be compared between both the groups.

We hypothesise that ketamine has analgesic effect at low dose and therefore, leads to reduction by 10% in intraoperative fentanyl consumption in patients undergoing lumbar fixation surgery

 
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