| CTRI Number |
CTRI/2025/02/080761 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of NIRS to compare the oxygen level between opioid and cognitive function in elderly patients after surgery |
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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 |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Puneet Khanna |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science (AIIMS), New Delhi. |
| Address |
5th Floor, Room No: 5008(A), Teaching Block,
All India Institute of Medical Science (AIIMS), New Delhi.
New Delhi DELHI 110029 India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Puneet Khanna |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science (AIIMS), New Delhi. |
| Address |
5th Floor, Room No: 5008(A), Teaching Block,
All India Institute of Medical Science (AIIMS), New Delhi.
New Delhi DELHI 110029 India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Puneet Khanna |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science (AIIMS), New Delhi. |
| Address |
5th Floor, Room No: 5008(A), Teaching Block,
All India Institute of Medical Science (AIIMS), New Delhi.
New Delhi DELHI 110029 India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, New Delhi, Ansari Nagar-110029 |
|
|
Primary Sponsor
|
| Name |
Dr Puneet Khanna |
| Address |
Room No. 5008 A, 5th Floor, Department of Anaesthesiology, Pain Medicine and Critical Care,Teaching Block, AIIMS, New Delhi, Ansari Nagar-110029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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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 |
All India Institute of Medical Science (AIIMS), New Delhi. |
Department of Anesthesiology, and Department of Surgery, AIIMS, 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 For Biomedical and Health Research, AIIMS, New Delhi. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F112||Opioid dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Opioid Based (Group A): |
Opioid anesthesia- propofol (1-2 mg/kg), fentanyl (1-2 µg/kg), and atracurium (0.5 mg/kg) will be administered from pre-surgery to the end of surgery.
|
| Comparator Agent |
Opioid Sparing (Group B, Non-Opioid Based) |
Non-Opioid anesthesia- propofol (1-2 mg/kg), ketamine (0.5mg/kg), and atracurium (0.5 mg/kg) will be administered from pre-surgery to the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.)Age above 60 years. 2.) Undergoing major surgery over 60 minutes. 3.) Can give informed consent themselves. 4.) Minimum cognitive performance required to participate is ACE-III score more than 88.
|
|
| ExclusionCriteria |
| Details |
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 any 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 (e.g.: antidepressants antipsychotics, sedatives).
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1. The association between NIRS and the incidence of POCD in patients.
2. Measurement of cerebral hypoperfusion between opioid and opioid-sparing anesthesia groups.
|
1.) Postoperative delirium- Immediately post operatively and 24 hours post operatively.
2.) Post operative cognitive dysfunction- 24 and 48 hours post operatively, at 30 days post operatively.
3.)Cerebral Oxygenation- 10 minutes intra operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of POCD between opioid and opioid-sparing anesthesia groups. |
24 hrs Post-operative(ACE-III) |
|
|
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)
|
27/02/2025 |
| 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="3" Months="0" 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
|
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
Laparoscopic surgeries in elderly patients are becoming increasingly common due to their minimally invasive nature and faster recovery times [1]. However, these procedures often involve prolonged operative durations and the use of opioids for pain management. While opioids provide effective analgesia, their systemic effects, such as reduced cerebral blood flow, may contribute to cerebral hypoperfusion, potentially leading to post-operative cognitive dysfunction (POCD) [2]. Elderly patients undergoing laparoscopic surgeries are at increased risk of POCD, which can impair recovery and quality of life [3]. Opioids, commonly used for intraoperative analgesia, may exacerbate this issue by causing cerebral hypoperfusion [4]. Despite advances in anesthesia protocols, there is limited evidence on the direct association between opioid use, cerebral perfusion (measured by NIRS), and cognitive outcomes. Near-infrared spectroscopy (NIRS) is a non-invasive technique that allows real-time monitoring of cerebral oxygen saturation [5]. It can detect changes in frontal lobe perfusion, offering a valuable tool for understanding how anesthesia impacts cerebral blood flow and cognitive outcomes. Opioid-sparing anesthesia regimens, such as those using dexmedetomidine, have shown promise in minimizing the risk of cognitive decline, but their effect on cerebral oxygenation remains underexplored [6]. This double-blind randomized controlled trial will recruit 100 patients. During anesthesia, the participants will be divided into two groups: Group A (50 patients: opioid-based anesthesia using propofol + fentanyl) and Group B (50 patients: non-opioid-based anesthesia using propofol + ketamine). NIRS technology will then be used to monitor regional cerebral oxygen saturation in real time. Before and after the surgery, patients will be asked questions to check for cognitive dysfunction. For example, patients may be asked to name the colours written in text, connect a set of dots as quickly as possible to assess visual attention and executive function, and perform a task where they trace a path from a start point to an endpoint through a complex network within 15–60 minutes. Orientation will also be assessed by asking patients for the date, year, day, place, and city. Additionally, short-term memory will be tested by having patients read five words and repeat them after completing other tasks. Three pictures of animals will be shown, and patients will be asked to name each one. The study aims to optimize anesthesia practices, reduce cognitive complications, and improve recovery outcomes in elderly patients.
References: - Bates AT, Divino C. Laparoscopic surgery in the elderly: a review of the literature. Aging and disease. 2015 Mar;6(2):149.
- Goettel N, Burkhart CS, Rossi A, Cabella BC, Berres M, Monsch AU, Czosnyka M, Steiner LA. Associations between impaired cerebral blood flow autoregulation, cerebral oxygenation, and biomarkers of brain injury and postoperative cognitive dysfunction in elderly patients after major noncardiac surgery. Anesthesia & Analgesia. 2017 Mar 1;124(3):934-42.
- Li Y, He R, Chen S, Qu Y. Effect of dexmedetomidine on early postoperative cognitive dysfunction and peri-operative inflammation in elderly patients undergoing laparoscopic cholecystectomy. Experimental and therapeutic medicine. 2015 Nov 1;10(5):1635-42.
- Saber A. Perioperative care of elderly surgical patients. American Medical Journal. 2013 Jan 1;4(1):63.
- Takegawa R, Hayashida K, Rolston DM, Li T, Miyara SJ, Ohnishi M, Shiozaki T, Becker LB. Near-infrared spectroscopy assessments of regional cerebral oxygen saturation for the prediction of clinical outcomes in patients with cardiac arrest: a review of clinical impact, evolution, and future directions. Frontiers in Medicine. 2020 Oct 29;7:587930.
- Ference RR. Dexmedetomidine Use for Reduction in Postoperative Delirium in Geriatric Surgical Populations (Doctoral dissertation, The University of Arizona).
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