| CTRI Number |
CTRI/2024/12/078692 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To find out how of the use of either Remifentanil or Fentanyl with Propofol-based anesthesia has effect on easier awakening from anaesthesia & patient stability during a Craniotomy. |
|
Scientific Title of Study
|
Evaluation of the effect of Remifentanil vs Fentanyl as an adjunct to Propofol-based TIVA on Ease of Emergence & Intraoperative Haemodynamic Stability in patients undergoing Craniotomy : A Randomised 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 |
Dr Eesha Banerjee |
| Designation |
DrNB Neuroanesthesia Resident |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
2nd floor. Department of Neuroanesthesia and Critical Care. Institute of Neurosciences Kolkata. 185/1 A J C Bose Road.
2nd floor. Dept of Neuroanesthesia. Institute of Neurosciences Kolkata.
Kolkata
WEST BENGAL
700017
India |
| Phone |
7501724995 |
| Fax |
|
| Email |
eesha5banerjee70@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kallol Deb |
| Designation |
Senior Consultant Neuroanesthesia, Institute of Neuroscience Kolkata |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
2nd floor. Department of Neuroanesthesia and Critical Care. Institute of Neurosciences Kolkata. 185/1 A J C Bose Road.
2nd floor. Dept of Neuroanesthesia. Institute of Neurosciences Kolkata.
Kolkata
WEST BENGAL
700017
India |
| Phone |
9830028915 |
| Fax |
|
| Email |
kalloldeb15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Eesha Banerjee |
| Designation |
Senior Consultant Neuroanesthesia |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
2nd floor. Department of Neuroanesthesia and Critical Care. Institute of Neurosciences Kolkata. 185/1 A J C Bose Road.
2nd floor. Dept of Neuroanesthesia. Institute of Neurosciences Kolkata.
Kolkata
WEST BENGAL
700017
India |
| Phone |
9830028915 |
| Fax |
|
| Email |
kalloldeb15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Neurosciences Kolkata. 185/1 A J C Bose Road, Kolkata. West Bengal. 700017 |
|
|
Primary Sponsor
|
| Name |
Institute of Neurosciences Kolkata |
| Address |
2nd floor. Department of Neuroanesthesia. Institute of Neurosciences Kolkata. 185/1 A J C Bose Road. West Bengal. 700017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Eesha Banerjee |
Institute of Neurosciences Kolkata |
2nd floor. Department of Neuroanesthesia. Institute of Neurosciences Kolkata. 185/1 A J C Bose Road.
Kolkata
WEST BENGAL |
7501724995
eesha5banerjee70@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC I-NK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl bolus |
Patients allocated to this group will receive Fentanyl boses in dose of 1 mcg/kg every 2 hourly intraoperatively. |
| Intervention |
Remifentanil Infusion |
Patients allocated to this group will receive Remifentanil TCI infusion based on body weight, height, age and sex, to meet a target plasma concentration of 6-8 ng/ml intraoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I, II, III
Either gender
BMI less than35 kg/m2
Any craniotomy for both supra-tentorial & infra-tentorial space occupying lesion
GCS of 15/15
Duration of surgery of 4 hr |
|
| ExclusionCriteria |
| Details |
Patient refusal
body mass index more than 35 kg/m2,
GCS less than 15/15
H/o previous craniotomy
If rapid postoperative return to normal consciousness was unlikely, owing to the location or size of lesion or postoperative ventilation is planned
uncontrolled hypertension/ significant CAD/Â cardiac conduction block/ severe renal dysfunction/ CLD/ chronic obstructive pulmonary disease (GOLD 3/4) / neuropsychiatric disorders
chronic pain requiring opioid analgesia,
reported allergy to either study drug,
patients having awake craniotomies or craniotomies requiring intraoperative CT/ magnetic resonance scanning (because the length of surgery will be much longer). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ease of extubation:
1.Time to eye opening
2.Time to extubation
3.Cough
4.Sedation
5.Pain |
During extubation ( 0 min) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate |
At induction of anesthesia, head pinning, incision, during burring, 30 min, 1 hr,2 hr, 3 hr, 4 hr |
| Systolic blood pressure |
At induction of anesthesia, head pinning, incision, during burring, 30 min, 1 hr,2 hr, 3 hr, 4 hr |
| Diastolic blood pressure |
At induction of anesthesia, head pinning, incision, during burring, 30 min, 1 hr,2 hr, 3 hr, 4 hr |
| Mean arterial blood pressure |
At induction of anesthesia, head pinning, incision, during burring, 30 min, 1 hr,2 hr, 3 hr, 4 hr |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/01/2025 |
| 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="0"
Months="6"
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
|
With the very recent introduction of remifentanil into the Indian drug armamentarium, interest to utilise the drug in anesthesia practices for various surgeries including craniotomies has gained interest. This offered an opportunity to study the efficacy of remifentanil infusion versus fentanyl boluses as part of a TIVA regimen for patients posted for craniotomy. We therefore want to test the hypotheses that remifentanil- propofol TIVA provides better extubating conditions and smooth emergence in craniotomy patients providing an optimum intraoperative haemodynamic control. |