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CTRI Number  CTRI/2020/11/028784 [Registered on: 02/11/2020] Trial Registered Prospectively
Last Modified On: 29/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Anesthesia for elderly patients undergoing brain tumor surgery without opioids. 
Scientific Title of Study   OPIoid sparing Anesthesia Technique for supratentorial craniotomy in geriatric patients [OPIATE]: a randomized open labelled study  
Trial Acronym  OPIATE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Indu Kapoor 
Designation  Associate Professor 
Affiliation  AIIMS, NEW DELHI 
Address  Department of Neuroanesthesiology and Critical Care AIIMS New Delhi
ANSARI NAGAR, SOUTH DELHI
New Delhi
DELHI
110029
India 
Phone  09013439134  
Fax    
Email  dr.indu.me@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Indu Kapoor 
Designation  Associate Professor 
Affiliation  AIIMS, NEW DELHI 
Address  Department of Neuroanesthesiology and Critical Care AIIMS New Delhi
ANSARI NAGAR, SOUTH DELHI
South
DELHI
110029
India 
Phone  09013439134  
Fax    
Email  dr.indu.me@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Indu Kapoor 
Designation  Associate Professor 
Affiliation  AIIMS, NEW DELHI 
Address  Department of Neuroanesthesiology and Critical Care AIIMS New Delhi
ANSARI NAGAR, SOUTH DELHI
South
DELHI
110029
India 
Phone  09013439134  
Fax    
Email  dr.indu.me@gmail.com  
 
Source of Monetary or Material Support  
AIIMS NEW DELHI 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Department of Neuroanaesthesiology and Critical Care 
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 
Indu Kapoor  NEUROSCIENCE CENTER  Department of Neuroanesthesiology and critical care AIIMS New Delhi
South
DELHI 
09013439134

dr.indu.me@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Ethics Committee  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 
Intervention  Dexmedetomidine and scalp block  Dexmedetomidine bolus @1mcg/kg over 10 mins before induction followed by 0.2-0.7 mcg/kg/hr. + Scalp block with ropivacaine [0.25%] after induction of anesthesia [Group DS] 
Comparator Agent  Opioids  Fentanyl @ 1mcg/kg at induction followed by 1 mcg/kg/hr for maintenance [Group F]  
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Written informed consent
2. American Society of Anesthesiologists class I&II
3. Age of >65 years
4. Either gender
5. Supratentorial brain tumor with tumor diameter of ≤ 40 mm
6. Full Glasgow coma score (E4V5M6)
7. Estimated operative time of ≤ 6 hours and anesthesia time of ≤ 8 hours
 
 
ExclusionCriteria 
Details  1. Non consenting patient
2. Any history of previous brain surgery
3. Current or past history of any cardiac disease or medication
4. Any history of lung disease, liver or kidney dysfunction
5. Patients who had sensitivity to opioids, dexmedetomidine, ropivacaine
6. Body mass index of > 35 kg/m2
7. Preoperative cognitive dysfunction
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Time to emergence
2.Postoperative immediate pain  
1.From discontinuation of anesthetics to eye opening on command in minutes
2. 10 minutes after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
1. Extubation time  1. From discontinuation of anesthetics to tracheal extubation in minutes 
2. Postoperative delirium   2. Assessed using CAM-ICU 60 minutes after extubation 
3. Postoperative early cognitive dysfunction   Assessed using MMSE 60 minutes after extubation] 
4. Postoperative side effects: nausea,vomiting, shivering, hemodynamic instability, respiratory depression   Postoperative period[24 hrs] 
5. Other respiratory parameters (any subclinical respiratory depression): Ph, PaO2, PaCo2, Hco3, Lact, Sao2, Hb  Postoperative period [24 hrs] 
6. Time for first rescue analgesic:  Postoperative period [24 hrs] 
7. Length of ICU stay

 
8. Length of Hospital stay
 
9. Intraoperative brain relaxation [Cerebral relaxation score]
 
intraoperative period 
10. Intraoperative hemodynamic disturbances [hypotension, bradycardia]

 
intraoperative period 
11. Intraoperative fentanyl consumption
 
End of surgery 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="22" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/11/2020 
Date of Study Completion (India) 09/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Opioids have been an integral part of anesthesia practice and are not without side effects. Geriatric population have more pronounced opioid side effects during perioperative period which include, sedation, respiratory depression, shivering, nausea and vomiting, dizziness, constipation, pruritus and ileus. Specifically in geriatric patient undergoing neurosurgical procedures, increased sensitivity towards opioids, disturbed cerebral autoregulation in the postoperative period, coupled with opioid induced hypotension, respiratory depression and carbon dioxide retention leading to an undesirable rise in intracranial pressure and further sedation caused by these drugs may lead to a delayed emergence. In these patients time to emergence from anesthesia is important for rapid neurological examination. A depressed level of consciousness usually indicates residual anesthesia, most commonly due to an opioid overdose (bilaterally constricted pupils), but may be also be due to other causes, such as an intracranial hematoma, cerebral edema, nonconvulsive status epilepticus, hypoglycemia, electrolyte disturbances, hypothermia, pneumocephalus, vascular occlusion, and ischemia. Supratentorial tumors are the most common intracranial neoplasms in geriatric patients patients (>65 years). Important eloquent areas involved in speech, sensorimotor functions, white matter tracts and primary visual cortex, all are in supratentorial region. Resection of tumor that involve or are in close proximity to these areas are associated with a high risk of poor postoperative neurocognitive recovery, language dysfunction and motor weakness. While mild cognitive impairment and lethargy is not uncommon in geriatric patients in the immediate postoperative period, failure to awaken within 5- 10 minutes of cessation of anesthetic drugs should prompt a search for other potential causes of a delayed emergence. The practice of opioid sparing anesthesia [OSA] has the potential to innovate and transform the practice of neuroanesthesia and enhance the postoperative recovery profile, especially in geriatric patients. The OSA technique in the form of scalp block and combination of drugs such as dexmedetomidine, ketamine, lignocaine, magnesium etc can be used to preclude the use of opioids.  With regard to postoperative recovery, presently there are no trials that have studied the effect of OSA in terms of time to emergence from cessation of anesthesia in geriatric patients undergoing supratentorial craniotomy surgery. The hypothesis of our study is that an OSA technique would be a better alternative to the conventional anesthetic technique using opioid throughout the surgery in geriatric neurosurgical patients undergoing craniotomy for supratentorial tumor surgery.


 
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