CTRI

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CTRI Number

CTRI/2022/11/046943 [Registered on: 01/11/2022] Trial Registered Prospectively

Last Modified On:

06/06/2023

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 EVALUATE THE EFFCT OF ORAL IVABRADINE FOR ATTENUATION OF HEMODYNAMIC FOLLOWING LARYNGOSCOPY AND INTUBATION IN PATIENT UNDERGOING ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA

Scientific Title of Study

Use of Ivabradine for Attenuation of Stressor Response following Laryngoscopy and Intubation in patient undergoing surgery under general anaesthesia in tertiary care hospital: a double blind placebo controlled randomized trial.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	TETIKCHA GURUNG
Designation	PG RESIDENT
Affiliation	SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES
Address	DEPARTMENT OF ANAESTHESIOLOGY, CENTRAL REFERRAL HOSPITAL, 5TH MILE TADONG East SIKKIM 737102 India
Phone	6294043159
Fax
Email	gurung.tetikcha17@gmail.com

Details of Contact Person
Scientific Query

Name	DR BK GANDHI
Designation	PROFESSOR AND HEAD OF DEPARTMENT
Affiliation	SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES
Address	DEPARTMENT OF ANAESTHESIOLOGY, CENTRAL REFERRAL HOSPITAL, 5TH MILE TADONG STAFF QUARTER SMIMS 5TH MILE TADONG East SIKKIM 737102 India
Phone	9831779215
Fax
Email	basantakumar.g@smims.smu.edu.in

Details of Contact Person
Public Query

Name	TETIKCHA GURUNG
Designation	PG RESIDENT
Affiliation	SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES
Address	DEPARTMENT OF ANAESTHESIOLOGY, CENTRAL REFERRAL HOSPITAL, 5TH MILE TADONG East SIKKIM 737102 India
Phone	6294043159
Fax
Email	gurung.tetikcha17@gmail.com

Source of Monetary or Material Support

SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES

Primary Sponsor

Name	SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES
Address	CENTRAL REFERRAL HOSPITAL, 5TH MILE TADONG
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
TETIKCHA GURUNG	CENTRAL REFERRAL HOSPITAL	ROOM NO 311 PG HOSTEL SMIMS East SIKKIM	6294043159 gurung.tetikcha17@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
SMIMS/IEC/2022-109	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent
Modification(s)

Type	Name	Details
Comparator Agent	placebo	GROUP II WILL RECIEVE PLACEBO ONE HOUR BEFORE INDUCTION OF ANAESTHESIA AND HEMODYNAMIC PARAMETER WILL BE MEASURED AT SPECIFIED TIME POINTS.
Intervention	USE OF IVABRADINE FOR ATTENUATION OF HEMODYNAMIC STATUS FOLLOWING LARYNGOSCOPY AND INTUBATION.	GROUP I WILL RECIEVE 5 MG IVABRADINE ONE HOUR BEFORE INDUCTION OF ANAESTHESIA AND HEMODYNAMIC PARAMETER WILL BE MEASURED AT SPECIFIED TIME POINTS.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	All American Society of Anaesthesiology (ASA) physical status I, aged 18- 50 yrs posted for elective non cardiac surgery under general anaesthesia requiring endotracheal intubation who consent to be part of the study

ExclusionCriteria

Details

1. Patient not giving consent for the study.
2. ASA status >II

6
3. Anticipated difficult intubation(Mallampati Class III and IV,
thyromental height < 6 cm , inter-incisor distance <3cm and cervical
instability.
4. Baseline heart rate < 60 b/min or >90 b/min
5. Baseline BP <90/50mm Hg (65) or >140/85mm Hg (105)
6. History of syncope, palpitation, chest pain or cardiac/ respiratory
illness, liver or renal dysfunction.
7. History of substance abuse.
8. Those with ECG abnormalities.

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
the change in heart rate, blood pressure and MAP (mean arterial pressure) following laryngoscopy and intubation, which shall be compared between the study and control group. Unattenuated these changes can be 20% or more.	24 hours of total study duration in each case starting from the oral intake of study drug.

Secondary Outcome

Outcome	TimePoints
To assess incidence of side effects and complication if any due to study drug	24 hrs in postoperative period after intake of study drug

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)

01/11/2022

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="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Patients undergoing elective surgical procedure under general anaesthesia

during the study period will be the population group. the study population will receive tab Ivabradine 1 hr before induction of anesthesia and hemodynamic parameter will be measured on specific time period.Research is still going on to evaluate the effectiveness of oral ivabradine in maintenance of hemodynamic stability.