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CTRI Number  CTRI/2022/08/044598 [Registered on: 03/08/2022] Trial Registered Prospectively
Last Modified On: 28/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Opioid Free Anaesthesia For Brain Surgery 
Scientific Title of Study   Opioid Free Anaesthesia For Craniotomy In Supratentorial Tumors 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DAVINDER JIT SINGH 
Designation  Senior Resident Academics 
Affiliation  AIIMS NEW DELHI 
Address  Dept of Neuroanaesthesia, Cardio Neuro Centre, AIIMS NEW DELHI, Ansari Nagar East, 110029
Dept of Neuroanaesthesia, Cardio Neuro Centre, AIIMS NEW DELHI, Ansari Nagar East, 110029
South
DELHI
110029
India 
Phone  08728055241  
Fax    
Email  davinderjit98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Hemanshu Prabhakar 
Designation  Professor 
Affiliation  AIIMS, NEW DELHI 
Address  Dept of Neuroanaesthesia, Cardio Neuro Centre,6 floor, Room no 10, AIIMS NEW DELHI, Ansari Nagar East

South
DELHI
110029
India 
Phone  08728055241  
Fax    
Email  prabhakaraiims@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DAVINDER JIT SINGH 
Designation  Senior Resident Acad 
Affiliation  AIIMS NEW DELHI 
Address  Dept of Neuroanaesthesia,6th floor, Cardio Neuro Centre, AIIMS NEW DELHI, Ansari Nagar East

South
DELHI
110029
India 
Phone  08728055241  
Fax    
Email  davinderjit98@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS 
Address  New delhi 
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 
Dr Davinder Jit Singh  AIIMS New Delhi  Department of Neuroanaesthesia, OT block 7th Floor, Cardio Neuro Centre,AIIMS New Delhi, Ansari Nagar East 110029
South
DELHI 		 8728055241

davinderjit98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE OF AIIMS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C710||Malignant neoplasm of cerebrum, except lobes and ventricles,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DEXMEDETOMIDNE  Dexmedetomidine (infusion) 0.2 to 0.7 mcg/kg/hr will be used with scalp block for multimodal opioid free anaesthetic technique in elective supratentorial craniotomies. Duration of approximately 8hrs. 
Comparator Agent  FENTANYL  Fentanyl(infusion) 1mcg/kg/hr will be used as for intraoperative analgesia. Duration of approximately 8hrs. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Written informed consent
2. Undergoing craniotomy for elective supratentorial tumour excisions, size <4 cm in any dimensions.
3. American Society of Anesthesiologists class I&II
 
 
ExclusionCriteria 
Details  1. Patient’s refusal
2. Anticipated difficult airway/ intubation including those with cervical spine disease.
3. Pregnancy
4. Body mass index of > 35 kg/m2
5. Patients who had sensitivity to opioids, dexmedetomidine, ropivacaine (study drugs)
6. Patients with cardiovascular diseases or respiratory diseases
7. Previous history of craniotomy or any intracranial procedure
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary: To compare opioid free anesthetic technique with conventional opioid based anesthetic technique in terms of emergence from anaesthesia in patients undergoing elective supratentorial craniotomy.
1. Emergence time (in minutes)
2. Extubation time (in minutes)

 		 At emergence and extubation  
 
Secondary Outcome  
Outcome  TimePoints 
1. Intraoperative Hemodynamic response, such as heart rate and mean art. Pressure.
2. Rate of Post operative nausea vomiting [PONV]
3. Postoperative pain assessed post extubation in OT and subsequently at 4,6,12 and 24 hours in ICU using the 11- point Numeric Rating Scale.
4. Emergence quality assessed using Richmond Agitation Sedation Scale.
5. Duration of ICU stay (days)
6. Duration of hospital stay (days)
7. Complications if any.
 		 Baseline, intraoperative period,
and till 24hrs in ICU 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   10/08/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In the preoperative period, a written, informed consent will be obtained from patients meeting the inclusion criteria after detailed explanation of study.Patients will either receive fentanyl @2mcg/kg at induction followed by 1mcg/kg/hr for maintainance (Group F) or Dexmedetomidine bolus@1mcg/kg over 10min before induction followed by 0.2 to 0.7mcg/kg/hr and scalp block with ropivacaine (0.25%) after induction of anaesthesia (Group DS). Propofol 1.5 to 2mg/kg will be used for induction of anaesthesia. Tracheal intubation with cuffed portex tube will be facilitated with rocuronium 1mg/kg.Both the groups will receive skin infiltration with lignociane 2% (3-5ml) for skull pin insertion. Anaesthesia will be maintained with air/oxygen mixture (1:1) at flow rate of 2lt/min.Propofol infusion at 100 to 150mcg/kg/min will be used for mainatinace intaop. Intraoperative nuromuscular blockade will be maintained with rocuronium 0.2 to 0.3mg/kg/hr infusion. fentanyl and rocuronium infusion will be stopped at start of dural closure. in group DS, dexmedetomidine infusion will be stopped at start of skin closure. for both groups propofol infusion will be stopped at start of skin closure. Patients in both groups will receive IV paracetamol 0.15gm/kg and ondansetrone 0.1mg/kg at start of skin closure. emergence and extubation times will be recorded in both groups after reversal agents are given at end of procedure. Quality of emergence by RAAS will be noted during emergence, at 10min and 4hrs post extubation. Patients hemodynamics will be monitored from preinduction (baseline), intraop, postop in ICU. Pain will be assessed using NRS scale in OT and 4,6,12,24 hrs in ICU. Duration of ICU stay and hospital stay will be recorded. 
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