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CTRI Number  CTRI/2024/03/064677 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 15/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Dexmedetomidine versus fentanyl as adjuvants to TIVA in craniotomies  
Scientific Title of Study   Dexmedetomidine and fentanyl as adjuvants to propofol based total intravenous anaesthesia in patients undergoing elective supratentorial craniotomies for intracranial space occupying lesions: A 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  SRINIVASAN 
Designation  Post graduate resident 
Affiliation  Department of Anaesthesiology and Critical care, AIIMS Bathinda 
Address  Room No:207, PG Hostel, AIIMS Bathinda.

Bathinda
PUNJAB
151001
India 
Phone  8220844375  
Fax    
Email  sriniguru98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anju Grewal 
Designation  Head of the Department 
Affiliation  All India Institute of Medical Sciences Bathinda 
Address  Room No: 145, Department of Anaesthesiology and Critical care, AIIMS, Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9815482626  
Fax    
Email  dranjugrewal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anju Grewal 
Designation  Head of the Department 
Affiliation  All India Institute of Medical Sciences Bathinda 
Address  Room No: 145, Department of Anaesthesiology and Critical care, AIIMS, Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9815482626  
Fax    
Email  dranjugrewal@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and critical care, AIIMS Bathinda, Punjab 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  All India Institute of Medical Sciences, Mandi Dabwali Road, Bathinda, Punjab 151001. 
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 Srinivasan  AIIMS Bathinda  Room No: 207, Department of Anaesthesiology and Critical care, AIIMS Bathinda.
Bathinda
PUNJAB 
8220844375

sriniguru98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Institutional 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  Group A: Dexmedetomidine is used as an adjuvant to propofol-based TIVA  Propofol consumption will be measured till the end of the surgery 
Comparator Agent  Group B: Fentanyl is used as an adjuvant to propofol-based TIVA  Propofol consumption will be measured till the end of the surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients between 18-70 years of age including all genders.
2. American Society of Anaesthesiologists Physical status I to III.
3. Scheduled for elective craniotomy for supratentorial brain tumors under general anaesthesia.
 
 
ExclusionCriteria 
Details  1. Patients refusing to give consent.
2. Patient with body mass index ≥ 35 kg/m².
3. Pregnant patients.
4. Patients allergic to any of the study drugs.
5. Preoperative GCS less than 13.
6. Patients with bleeding diathesis
 
 
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 assess the mean propofol consumption at the end of the surgery (in mcg/kg/min) in all the patients.  At the end of the surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the intra-operative hemodynamic profile between the two groups.  At 5-minute intervals till 15 minutes after induction, followed by every 30 minutes till the end of the surgery 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   10/04/2024 
Date of Study Completion (India) 05/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 05/09/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  

Patients will be randomly allocated into two groups (Group A and Group B) using a computer-generated table.

Group A: Dexmedetomidine will be used as an adjuvant to propofol-based TIVA.

      Group B: Fentanyl will be used as an adjuvant to propofol-based TIVA

All patients will be shifted to the operating room, where ASA standard monitors will be attached and heart rate (HR), mean arterial pressure (MAP), systolic blood pressure (SBP), diastolic blood pressure (DBP), oxygen saturation (SpOâ‚‚) and electrocardiogram (ECG) will be noted. BIS monitoring sensors will be attached to monitor the depth of anaesthesia. BIS monitoring consists of a sensor, a digital converter and a monitor. It involves the application of four electrodes on the forehead, which pick up signals from the cerebral cortex and transfer them to the digital signal converter. The forehead will be cleaned with an alcohol-based solution and digital pressure applied over the sensor leads before placement (23).

All the patients will be pre-oxygenated with an appropriately sized face mask with 100% oxygen for 3 minutes. Induction will be done according to the allocated group.

Group A: Patients in this group will receive a loading dose of intravenous dexmedetomidine 1 mcg/kg over 10 minutes followed by a maintenance dose of 0.5 mcg/kg/hr. Titrated doses of intravenous propofol will be administered as a bolus to achieve BIS 40-60. After checking the ability to mask ventilate, 0.1mg/kg vecuronium will be administered intravenously. After three minutes of mask ventilation, the airway will be secured with an appropriately sized endotracheal tube. Dexmedetomidine infusion will be continued at the maintenance dose of 0.5mcg/kg/hr. Propofol infusion will be initiated at 100mcg/kg/min and titrated to BIS 40-60.

 Group B: Patients in this group will be induced anaesthesia with 2mcg/kg of intravenous fentanyl followed by intravenous propofol 2-2.5mg/kg. After checking the ability to mask ventilate, 0.1mg/kg vecuronium will be administered intravenously. After three minutes of mask ventilation, the airway will be secured with an appropriately sized endotracheal tube. Fentanyl infusion will be initiated at a dose of 1mcg/kg/hr. Propofol infusion will be initiated at 100mcg/kg/min and titrated to BIS of 40-60. 

 The hemodynamic parameters such as HR, MAP, SBP and DBP will be noted throughout the surgery at predetermined intervals. Urine output will be monitored at hourly intervals. All patients will be ventilated with an oxygen and air mixture at a ratio of 1:1, 6-8 ml/kg of tidal volume, I: E ratio of 1:2, positive end-expiratory pressure (PEEP) of 5cm of Hâ‚‚O and the respiratory rate adjusted to maintain an end-tidal carbon dioxide (EtCOâ‚‚) of 30-35mmHg. Intermittent intravenous vecuronium boluses will be given to all the patients. Fluid management will be based on standard hemodynamic monitoring: aiming to sustain a MAP ≥ 65 mmHg, systolic pressure variation (SPV) below 13%, hematocrit (HCT) ≥ 30% and ensuring urinary output ≥ 0.5 ml/kg/hour. The MAP will be maintained at a level of ± 20% compared to the baseline. Baseline MAP will be defined as the average value of the first three MAP measurements from preoxygenation to induction. If the MAP increases or decreases by more than 20% of baseline values, the rate of fluid infusion will be adjusted, and a vasopressor or an antihypertensive agent, like esmolol or labetalol, will be given accordingly. The intraoperative nasopharyngeal temperature will be maintained between 36 Â°C and 37 Â°C. The amount of blood loss during the surgery will be assessed from the collection container in the suction apparatus, craniotomy drape and the mopping pads used during the surgery. The total amount of fluids given to the patient throughout the surgery will be noted.

 Propofol infusion will be discontinued after completion of scalp sutures. The oropharynx will be gently suctioned using a soft suction catheter. The neuromuscular block will be reversed with intravenous neostigmine (0.05 mg per kg) & glycopyrrolate (0.01 mg per kg). The trachea will be extubated after objective extubation criteria are met. The entire duration of the surgery will be noted. Patients, who are not extubated, will be shifted to the intensive care unit (ICU).

 

 
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