| CTRI Number |
CTRI/2021/03/031837 [Registered on: 09/03/2021] Trial Registered Prospectively |
| Last Modified On: |
04/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARING EFFICACY OF TWO DIFFERENT DOSES OF FENTANYL FOR PREVENTING HYPERTENSION AND TACHYCARDIA WHILE GIVING GENERAL AENESTHESIA |
|
Scientific Title of Study
|
PROSPECTIVE RANDOMIZED DOUBLE BLIND COMPARATIVE STUDY OF EVALUATING EFFICACY AND SAFETY OF TWO DIFFERENT DOSES OF FENTANYL FOR PREVENTION OF SYMPATHOMIMETIC RESPONSE TO LARYNGOSCOPY AND INTUBATION IN CONTROLLED HYPERTENSIVE PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDhananjay Baraiya |
| Designation |
2nd year resident doctor |
| Affiliation |
B.J.Medical College |
| Address |
F3 ,1st floor
Department of aenesthesiology
Civil hospital
Ahmedabad
Bhavnagar
GUJARAT
380016
India |
| Phone |
9574775664 |
| Fax |
|
| Email |
ddbaraiya5664@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipshikha tripathi |
| Designation |
Professor, department of anesthesiology |
| Affiliation |
B.J.medical college |
| Address |
F3, 1st floor
Department of aenesthesiology
Civil hospital,
Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428408718 |
| Fax |
|
| Email |
drtripathi1961@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipshikha tripathi |
| Designation |
Professor, department of anesthesiology |
| Affiliation |
B.J.medical college |
| Address |
F3, 1st floor
Department of aenesthesiology
Civil hospital
Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428408718 |
| Fax |
|
| Email |
drtripathi1961@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government of Gujarat |
| Address |
Health and family welfare department,sachivalay, gandhinagar |
| 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 DHANANJAY BARAIYA |
Civil hospital |
5th floor, trauma centre, general surgery operation theatre, civil hospital, Ahmedabad
Ahmadabad
GUJARAT |
9574775664
ddbaraiya5664@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, B.J.Medical College and civil hospital, Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of intravenous fentanyl 2 mcg/kg or 3 mcg/kg |
Evaluation of efficacy of Intravenous injection of fentanyl 2 mcg/kg or 3 mcg/kg to prevent pressure response of laryngoscopy and intubation |
| Intervention |
Intravenous injection of fentanyl as a premedication |
Evaluation of efficacy of Intravenous injection of fentanyl 2 mcg/kg or 3 mcg/kg to prevent pressure response of laryngoscopy and intubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Informed written consent.
Patients posted for elective surgery under general Anesthesia requiring endotracheal intubation.
ASA physical status ||
Well controlled primary idiopathic hypertension(blood pressure less then or equal to 140/90) with maximum three anti hypertensive medications excluding beta blockers.
No end organ involvement due to hypertension.
BMI less then or equal to 25.
Modified Mallampati classification | and ||. |
|
| ExclusionCriteria |
| Details |
Patient refusing for consent.
Patients with diabetes, COPD, renal disease, cardiac diseases like IHD, valvular heart disease, AV conduction block, aortic stenosis, left ventricular failure etc.
Patient on drugs(sedatives,opioids,anti-psychotic drugs and beta blockers).
Anticipated difficult intubation.
BMI more then or equal to 25.
Intubation attempt lasting longer than 15 seconds.
Patient on more than 3 anti hypertensive medications.
Defaulter of taking anti hypertensive medications as per schedule. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Variation in heart rate, systolic blood pressure, diastolic blood pressure, ST-T changes, cardiac rhythm changes |
From injection of intravenous fentanyl to 20 minutes after endotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses sedative effect of fentanyl and to observe any complications |
From injection of intravenous fentanyl to 60 minutes after endotracheal extubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/03/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be done after completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- Laryngoscopy prior to intubation and intubation in itself produce significant hemodynamic stress response in the form of tachycardia and hypertension which is usually transient, returns to base line within 10-15 minutes and well tolerated by healthy individuals without cardio-respiratory compromise but can prove disastrous in the patient with cardiac and neurological diseases.
- Among opioids, fentanyl citrate has been identified as a most effective agent for this purpose. Fentanyl is effective in blunting stress response to intubation and has been used for this purpose in different doses titration ranging from 1.5µg/kg to 6µg/kg in different studies.
- In most of the studies, investigators assessed response of fentanyl in normotensive population to prevent hemodynamic stress response to intubation. Their findings cannot be applied to the hypertensive population which behave quite differently than normotensive group.
- This prompted us to plan the present study to evaluate the efficacy and safety of two different doses of fentanyl (2µg and 3µg) to prevent hemodynamic stress response to laryngoscopy and intubation in controlled hypertensive patients.
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