| CTRI Number |
CTRI/2025/07/090909 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
NIRS Monitor to compare regional cerebral oxygen saturation between opioid and opioid free anesthesia and post operative cognitive dysfunction in elderly patients |
|
Scientific Title of Study
|
Utilization of NIRS Monitor to compare regional cerebral oxygen saturation between opioid and opioid sparing anesthesia and post operative cognitive dysfunction in elderly patients undergoing laparoscopic surgery 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 |
Puneet Khanna |
| Designation |
Additional Professor |
| Affiliation |
All India INSTITUTE of Medical Sciences New Delhi |
| Address |
Dept of Anesthesiology, Pain Medicine and Critical Care
South
DELHI
110029
India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Khanna |
| Designation |
Additional Professor |
| Affiliation |
All India INSTITUTE of Medical Sciences New Delhi |
| Address |
Dept of Anesthesiology, Pain Medicine and Critical Care
DELHI
110029
India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Khanna |
| Designation |
Additional Professor |
| Affiliation |
All India INSTITUTE of Medical Sciences New Delhi |
| Address |
Dept of Anesthesiology, Pain Medicine and Critical Care
DELHI
110029
India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Ansar Nagar New delhi-110029 |
| Type of Sponsor |
Government 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 Puneet Khanna |
AlIMS New Delhi |
5th floor,
Department of Anesthesiology,
Ansari Nagar
New Delhi
New Delhi
DELHI |
9873106516
k.punit@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anesthesia with opioids |
Anaesthesia to be induced in all the patients with propofol 1 to 2 mg/kg, fentanyl 1- 2 microgms/kg and atracurium 0.5mg/kg
Multimodal analgesia regimen to be used in all the patients with a combination of intravenous paracetamol 15mg/kg and intravenous fentanyl 0.5mcg/kg given intraoperatively titrated with the hemodynamic parameters. When the patient has a greater than or equal to 20% increase in heart rate, analgesia to be supplemented with fentanyl boluses excluding the requirement for neuromuscular blockade |
| Comparator Agent |
Anesthesia without opioids |
Anesthesia to be induced with propofol 1 to 2 mg/kg, lignocaine 1.5 mg/kg and atracurium 0.5mg/kg after which the trachea to be intubated with appropriate size and type of endotracheal tube, then a bolus of lignocaine 1.5 mg/kg to be given over 30 minutes.the patients will receive an infusion of dexmedetomidine 0.3-0.8 mg/kg/hr titrating according to vitals of the patient. The infusion to be started post induction and continued till the patient was extubated. If hypotension (MAP less than 65 mm Hg) is observed, the infusion dose will be reduced. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age above 60 years.
2. Either sex
3. Undergoing laparoscopic cholecystectomy over 60 minutes
4. ASA I-II
5. Can give informed consent themselves
6. Minimum cognitive performance required to participate is ACE-III score more than 88
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1. Patients with a history suggestive of dementia (either listed in the medical record or reported by the patient) or any neurological disorder.
2. History of alcohol abuse, chronic opioid or other substance abuse
3. History of cerebral surgeries, stroke.
4. History suggestive of psychiatric disease like schizophrenia, dementia, anxiety or other disorder affecting cognition, mental dysfunction
5. Prescription of central nervous system–active medications (eg: antidepressants, antipsychotics, sedatives)
|
|
|
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 |
| To determine the association between opioids and frontal lobe hypoperfusion indicated by using NIRS. |
Baseline, every 10 minutes intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of post operative delirium
3. To determine the association between cerebral perfusion & incidence of postoperative cognitive dysfunction & delirium
|
Baseline
24 hours post surgery
48 hours post surgery
30 days post surgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/07/2025 |
| 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="0"
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
|
ostoperative cognitive decline (POCD) is common after surgery, especially in elderly patients. Opioid-based anesthesia, though effective for analgesia, is linked to cognitive impairment, respiratory depression, and other complications. Opioid-free anesthesia (OFA) using agents like dexmedetomidine, ketamine, and lidocaine may reduce these risks while preserving cognitive function. Cerebral oximetry via near-infrared spectroscopy (NIRS) helps monitor brain oxygenation, which influences cognitive outcomes. This study compares POCD incidence in elderly patients undergoing laparoscopic gastrointestinal surgery with opioid-based versus opioid-free anesthesia, correlating cognitive outcomes with intraoperative cerebral oxygenation levels to determine the potential benefits of OFA in reducing cognitive impairment. |