| CTRI Number |
CTRI/2022/09/045329 [Registered on: 08/09/2022] Trial Registered Prospectively |
| Last Modified On: |
06/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of a drug (Oral Ivabradine) on BP and Heart Rate during putting endotracheal tube with laryngoscopy. |
|
Scientific Title of Study
|
"The Effect of Oral Ivabradine on Attenuation of Hemodynamic Response to Laryngoscopy and Tracheal Intubation in Medically Controlled Hypertensive Surgical Patients: A Randomized Double Blind Controlled Trial" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Udita Naithani |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical college |
| Address |
Department of Anesthesiology,
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829414752 |
| Fax |
|
| Email |
uditanaithani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udita Naithani |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical college |
| Address |
Department of Anesthesiology
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829414752 |
| Fax |
|
| Email |
uditanaithani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riyaz Ahamed |
| Designation |
Junior Resident III |
| Affiliation |
RNT Medical college |
| Address |
Department of Anesthesiology
Udaipur
RAJASTHAN
313001
India |
| Phone |
7708033800 |
| Fax |
|
| Email |
riyazahamedk01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, RNT Medical college |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia |
| Address |
RNT Medical college, Udaipur |
| 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 Riyaz Ahamed |
General Surgery Operation Theatre |
2nd floor, MB Government hospital, RNT Medical college
Udaipur
RAJASTHAN |
7708033800
riyazahamedk01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT MEDICAL COLLEGE CONTROLLER ATTACHED HOSPITALS UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: N200||Calculus of kidney, (3) ICD-10 Condition: K639||Disease of intestine, unspecified, (4) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (5) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (6) ICD-10 Condition: O||Medical and Surgical, (7) ICD-10 Condition: O||Medical and Surgical, (8) ICD-10 Condition: K450||Other specified abdominal hernia with obstruction, without gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tablet Ivabradine |
Oral Ivabradine 5mg was given one hour before surgery |
| Comparator Agent |
tablet multivitamin |
oral multivitamin(one tablet) one hour before surgery |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade II
Controlled Hypertensive patients
Scheduled for elective surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
patients with systemic illness
patients with beta blockers
patients with difficult airway
patients with MI
BP >160100 on the day of surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haemodynamics changes |
up to 10 min after laryngoscopy and intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects |
Up to 24 hrs after completion of surgery |
|
|
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)
|
10/09/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
My clinical study is The Effect of Oral Ivabradine on Attenuation of Hemodynamic Response to Laryngoscopy and Tracheal Intubation in Medically Controlled Hypertensive Surgical Patients: A Randomized Double Blind Controlled Trial. Kindly consider it for CTRI registration |