| 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
|
|
|
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
|
|
|
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. |