| CTRI Number |
CTRI/2024/12/078060 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the impact of two doses of Labetalol on pre-induction quality in adult patients. |
|
Scientific Title of Study
|
A Randomised and Comparative study of attenuation of hemodynamic responses to Laryngoscopy and Endotracheal Intubation during pre-induction with two different Intravenous doses of Labetalol. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Isha Jhatakia |
| Designation |
Resident Doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia, Vadodara, Gujarat, 391760 India
Vadodara Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9825873000 |
| Fax |
|
| Email |
jhatakiaisha1697@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia, Vadodara, Gujarat, 391760 India
Vadodara Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760
Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara, Gujarat, India Pincode- 391760 |
|
|
Primary Sponsor
|
| Name |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Waghodiya, Pipariya, Vadodara, Gujarat, India Pincode- 391760 |
| 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 Dinesh Chauhan |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth, Waghodiya, Pipariya, Vadodara, Gujarat 391760, India
Vadodara
GUJARAT |
9099014672
drdinesh77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous injection of Labetalol 0.1 mg/kg |
Intravenous injection of Labetalol 0.1 mg/kg over 10 minutes just before laryngoscopy and endotracheal intubation.
At 1 min
At 3 min
At 5 min
At 7 min
At 10 min |
| Comparator Agent |
Intravenous injection of Labetalol 0.2 mg/kg |
Intravenous injection of Labetalol 0.2 mg/kg over 10 minutes just before laryngoscopy and endotracheal intubation.
At 1 min
At 3 min
At 5 min
At 7 min
At 10 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to sign written and informed consent.
Male or Female patients between 18 to 65 years of age.
Patients belonging to American Society of Anaesthesiologists(ASA) physical status I,II.
Patients posted for elective surgeries under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate in study.
Patients with Body Mass Index more than 30 mg/m2.
Patients with cardiovascular, cerebrovascular, hepatic and renal diseases.
Bradycardia, HR less than 70/min.
Arrhythmias.
Psychiatric patients.
Pregnancy and lactating women.
Patients belonging to the American Society of Anaesthesiologists (ASA) III and above.
Patients taking any type of medication for hypertension.
Patients allergic to the study drugs.
Patients with anticipated difficult airways.
Patients with neuromuscular diseases.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study hemodynamic and respiratory responses during endotracheal and laryngeal intubation. |
Preoperative
After test drug administration
During laryngoscopy and endotracheal intubation
At 1 min
At 3 min
At 5 min
At 7 min
At 10 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study any intra operative complications like bradycardia, hypotension, arrhythmias. |
Hemodynamic parameters will be recorded every 2 minutes for 10 minutes after intubation.
At 1 min
At 3 min
At 5 min
At 7 min
At 10 min |
|
|
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)
|
25/12/2024 |
| 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 Applicable |
| 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
|
To study effect of two different doses of Inj. Labetalol iv in attenuating hemodynamic stress responses to laryngoscopy and endotracheal intubation in adult patients- A randomised and comparative study of attenuation of hemodynamic responses to laryngoscopy and endotracheal intubation during pre-induction with two different intravenous doses of Labetalol in adult patients. |