| CTRI Number |
CTRI/2023/08/055936 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
29/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of change of blood pressure and heart rate response to placement of tube into windpipe by an instrument to see voice box inside throat by giving tablet Ivabradine (heart rate lowering medication) and tablet Clonidine (decreases heart rate) |
|
Scientific Title of Study
|
“Study of attenuation of the hemodynamic response to laryngoscopy and endotracheal intubation comparing oral Ivabradine and oral Clonidine - A Randomized control study “ |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEELAVANNAN PRASANTH VEDHA |
| Designation |
Post Graduate |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam
Madagadipet
Department of Anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam
Madagadipet
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9597797694 |
| Fax |
|
| Email |
prasanth2040@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NEELAVANNAN PRASANTH VEDHA |
| Designation |
POST GRADUATE |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam
Madagadipet
Department of Anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam
Madagadipet
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9597797694 |
| Fax |
|
| Email |
prasanth2040@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RANJAN R V |
| Designation |
PROFESSOR |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL
KALITHEERTHALKUPPAM
MADAGADIPET
Department of Anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthaljuppam
Madagadipet
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9600823772 |
| Fax |
|
| Email |
ranjanrv2005@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical College and Hospital
|
|
|
Primary Sponsor
|
| Name |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Anaesthesiology
SMVMCH
Kalitheerthalkuppam
Madagadipet
605107 |
| Type of Sponsor |
Private 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 Neelavannan Prasanth vedha |
Sri Manakula Vinayagar medical college and hospital |
Room no 107 / Department Of Anaesthesiology /Kalitheerthalkuppam , Madagadipet,
Pondicherry
PONDICHERRY |
9597797694
prasanth2040@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Manakula Vinayagar Medical College and Hospital ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient undergoing surgery under general anesthesia who needs endotracheal intubation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atropine |
During bradycardia within 1 minute to 5 mins |
| Comparator Agent |
oral clonidine |
clonidine will be used as cparing agent |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient should be of age 18-60 yrs.
Patient to get fit under ASA PS I and II
Patient should undergo Elective non cardiac surgery under General Anesthesia
|
|
| ExclusionCriteria |
| Details |
Patient who refused to give consent for study.
Patient with known hypersensitivity to these study drugs.
Baseline Heart rate less than 60
Baseline systolic Bp less than 100.
Those with ECG abnormalities.
Patients with history of chest pain/palpitations/syncope,
Patients with history of any visual disturbances, with Sick sinus syndrome.
Patients already on calcium channel blockers, azole antifungals, antiretroviral drugs and macrolide antibiotics, with hepatic impairment or renal dysfunction, pregnant and breastfeeding females and
9.
Patients in whom intubation is thought to be difficult (time taken to intubate >
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To the best of literature . There is no study evaluating the hemodynamic attenuation of laryngoscope
and endotracheal intubation comparing oral ivabradine & oral clonidine & with the previous
studies & previous records .however studies have done between clonidine vs gabapentin & ivabradine alone.
|
Laryngoscopic response till 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To the study the effect of these drugs on hemodynamic during intra operative & post operative
Period .
2. To study about the side effects & complications such as visual disturbances , arrhythmias, etc
, if any due to the study drugs.
|
At baseline ,1 hr , 2hrs , 3hrs , one week |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/08/2023 |
| 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)
|
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
|
The background of the study is that previously a tablet Ivabradine and Tablet Clonidine have been used in attenuation of laryngoscopic response on separate study for intubation response . And it was found with less or no side effects . And the purpose is to compare Tablet Ivabradine and Tablet clonidine during laryngoscope and to find which is better and stable |