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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 
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  
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 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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
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:

  1. Bates AT, Divino C. Laparoscopic surgery in the elderly: a review of the literature. Aging and disease. 2015 Mar;6(2):149.
  2. 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.
  3. 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.
  4. Saber A. Perioperative care of elderly surgical patients. American Medical Journal. 2013 Jan 1;4(1):63.
  5. 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.
  6. Ference RR. Dexmedetomidine Use for Reduction in Postoperative Delirium in Geriatric Surgical Populations (Doctoral dissertation, The University of Arizona).


 
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