| 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
|
|
|
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
|
|
|
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 (SpO₂) 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 H₂O and the respiratory rate adjusted to maintain an end-tidal carbon dioxide (EtCO₂) 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 °C and 37 °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). |