| CTRI Number |
CTRI/2025/05/087274 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Analysis of 2 mcg/kg versus 4 mcg/kg Fentanyl in Attenuating the Hemodynamic Stress Response to Laryngoscopy and Intubation During Intracranial Surgery |
|
Scientific Title of Study
|
A Randomized Comparative Study of Fentanyl 2 mcg/kg versus 4 mcg/kg in Attenuating the Hemodynamic Stress Response during Laryngoscopy and Endotracheal Intubation in Patients undergoing Intracranial Surgery |
| 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 Shobha purohit |
| Designation |
Senior professor |
| Affiliation |
SMS medical college and hospital |
| Address |
Department of Anesthesiology NSOT SMS MEDICAL
COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
INDIA
Jaipur
RAJASTHAN
302004
India |
| Phone |
7737050823 |
| Fax |
|
| Email |
purohit.shobha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobha purohit |
| Designation |
Senior professor |
| Affiliation |
SMS medical college and hospital |
| Address |
Department of Anesthesiology NSOT SMS MEDICAL
COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
INDIA
Jaipur
RAJASTHAN
302004
India |
| Phone |
7737050823 |
| Fax |
|
| Email |
purohit.shobha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umrao singh |
| Designation |
resident doctor |
| Affiliation |
SMS medical college and hospital |
| Address |
Department of Anesthesiology NSOT SMS MEDICAL
COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
INDIA
Jaipur
RAJASTHAN
302004
India |
| Phone |
6375167782 |
| Fax |
|
| Email |
umraogurjar92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR
RAJASTHAN INDIA -302004 |
|
|
Primary Sponsor
|
| Name |
SMS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR
RAJASTHAN INDIA -302004 |
| Type of Sponsor |
Government medical college |
|
|
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 Shobha Purohit |
SMS medical college and hospital |
Department of Anesthesiology NSOT SMS MEDICAL
COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
INDIA
Jaipur
RAJASTHAN |
7737050823
purohit.shobha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS medical college and attached hospital jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Intravenous Fentanyl at 2 mcg per kg |
Group A receives IV fentanyl at 2 mcg per kg
Fentanyl 2 mcg per kg administered before induction of anaesthesia
Hemodynamic parameters (HR SBP DBP MAP) are measured at baseline during laryngoscopy, immediately post-intubation and at set intervals post-intubation at 2 min 4 min 6min 15 minutes |
| Comparator Agent |
Intravenous Fentanyl at 4 mcg per kg |
Group B receives IV fentanyl at 4 mcg per kg
Intravenous Fentanyl 4 mcg per kg administered before induction of anaesthesia
Hemodynamic parameters (HR SBP DBP MAP) are measured at baseline during laryngoscopy, immediately post-intubation and at set intervals post-intubation at 2 min 4 min 6min 15 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status class 1 and 2 posted for elective intracranial surgery
Patient who will give informed written consent
Body weight 40 to 70 kg range |
|
| ExclusionCriteria |
| Details |
Patients having severe systemic illness and bleeding disorders,
Pregnant and lactating female
Patients allergic to study drugs
Anticipated difficult airways
|
|
|
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 |
Mean systolic BP
Mean diastolic BP
Mean of mean BP
Mean heart rate
Proportion of cases having adverse effects if any in both the groups |
0 MIKN 2 MIN 4 MIN 6 MIN 8 MIN 10 MIN 15 MIN |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare the proportion of patients developing intraoperative complications (hypotension, bradycardia tachycardia chest rigidity)
To assess and compare total dose of Propofol in mg required for induction of anaesthesia in both the groups
|
0 MIN 2 MIN 4 MIN 6 MIN 8 MIN 10 MIN 15 MIN |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
04/06/2025 |
| 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="2"
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
|
Laryngoscopy and tracheal intubation are known to cause significant sympathetic stimulation, resulting in transient increases in heart rate and blood pressure. These hemodynamic responses can be particularly dangerous in patients undergoing intracranial surgery due to the risk of elevated intracranial pressure and compromised cerebral perfusion. Fentanyl, a potent opioid analgesic, is commonly used to blunt these responses.
This study aims to compare the efficacy of two different fentanyl dosing regimens—2 mcg/kg versus 4 mcg/kg—in attenuating the hemodynamic changes associated with direct laryngoscopy and intubation in patients undergoing intracranial surgery. The primary outcomes include changes in heart rate, systolic and diastolic blood pressure, and mean arterial pressure during and after laryngoscopy. The study also evaluates the safety profile of each dose in this sensitive patient population. |