| CTRI Number |
CTRI/2021/06/034178 [Registered on: 11/06/2021] Trial Registered Prospectively |
| Last Modified On: |
09/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparaing effectiveness of two different doses of Fentanyl on blood pressure and heart Rate during laryngoscopy and tracheal intubation |
|
Scientific Title of Study
|
“Comparative effects of two different doses of fentanyl on attenuation of hemodynamic response to laryngoscopy and tracheal intubation: a prospective, randomized, control trial†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidhi Vishnubhai Patel |
| Designation |
Second year resident,Dept. of anaesthesia |
| Affiliation |
SSG Hospital,Vadodara |
| Address |
Department of anaesthesiology,
SSG Hospital,Jail road,Indira avenue,vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
8460878981 |
| Fax |
|
| Email |
vidhiwise@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshna Dharmendra Patel |
| Designation |
Assistant Professor |
| Affiliation |
SSG Hospital,Vadodara |
| Address |
202,Vaidehi Residency
44/1,Arunoday Society,
Alkapuri,
Vadodara
Vadodara
GUJARAT
390007
India |
| Phone |
9925013155 |
| Fax |
|
| Email |
dr.darshna1968@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidhi Vishnubhai Patel |
| Designation |
Second year resident,Dept. of anaesthesia |
| Affiliation |
SSG Hospital,Vadodara |
| Address |
Department of anaesthesiology,
SSG Hospital,Jail road,Indira avenue,vadodara
Vadodara
GUJARAT
380001
India |
| Phone |
8460878981 |
| Fax |
|
| Email |
vidhiwise@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College,Vadodara |
|
|
Primary Sponsor
|
| Name |
SSG Hospital Vadodara |
| Address |
Department of anaesthesiology,
SSG Hospital,Jail road,Indira avenue,vadodara
|
| 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 |
| Vidhi Vishnubhai Patel |
SSG Hospital Vadodara |
Department of anaesthesiology,
Government medical college,
Anandpura
Vadodara
Vadodara
GUJARAT |
8460878981
vidhiwise@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR BIOEDICAL AND HEALTH RESEARCH,GOVERNMENT MEDICAL COLLEGE,VADODARA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fentanyl 2.5mcg per kg |
To compare the effect of 2.5 mcg per kg fentanyl on
attenuation of haemodynamic stress response during laryngoscopy and endotracheal intubation
by measuring following parameters:
a)Heart rate
b) Systolic blood pressure/Diastolic blood pressure
c) Mean arterial pressure
d) Rate pressure product |
| Comparator Agent |
Fentanyl 5mcg per kg |
To compare the effect of 5mcg per kg fentanyl on
attenuation of haemodynamic stress response during laryngoscopy and endotracheal intubation
by measuring following parameters:
a)Heart rate
b) Systolic blood pressure/Diastolic blood pressure
c) Mean arterial pressure
d) Rate pressure product |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective surgery under General anaesthesia requiring intubation and
expected to last for more than one hour
ASA status I, II and III
Mallampatti airway assessment of Grade I and II. |
|
| ExclusionCriteria |
| Details |
Patients who refuse to give consent
Anticipated difficult airway
Patient having severe uncontrolled cardiovascular disease, respiratory disease, hepatic
disease, central nervous system disease or renal disease that is constant threat to life of
the patient. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Attenuation of haemodynamic stress response during laryngoscopy and endotracheal intubation which can be assesed
by measuring following parameters:
a)Heart rate
b) Systolic blood pressure/Diastolic blood pressure
c) Mean arterial pressure
d) Rate pressure product |
First 10 minutes after laryngoscopy and tracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced incidence of intraoperative complication in the form of pain on injection ,myoclonus, apnea, hypotension, bradycardia and tachycardia. |
First 10 minutes after laryngoscopy and tracheal intubation |
|
|
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)
|
20/06/2021 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be carried out in government medical college
vadodara.Overall purpose to carry out this study is to know the effect of
two different doses(2.5 and 5mcg/kg) of Fentanyl on haemodynamic responses to
laryngoscopy and endotracheal intubation.
|