| CTRI Number |
CTRI/2024/08/071934 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Nitro glycerine and Lignocaine spray during intubation |
|
Scientific Title of Study
|
Comparison of Nitro-glycerine spray and Lignocaine
spray for attenuating the pressor response during
laryngoscopy and endotracheal intubation in patients
undergoing elective surgery under general anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushpraj Brahme |
| Designation |
Postgraduate |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no 1 Department of Anaesthesia 1st floor Peoples Hospital PCMS and RC Karond Bypass Road Bhanpur Bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
7030091361 |
| Fax |
|
| Email |
Prince.brahme@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akanksha Agarwal |
| Designation |
Professor |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no 2 Department of Anaesthesia 1st floor Peoples Hospital PCMS and RC Karond Bypass Road Bhanpur Bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8989147838 |
| Fax |
|
| Email |
akankshaagarwal2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pushpraj brahme |
| Designation |
Postgraduate |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no 1 Department of Anaesthesia 1st floor Peoples Hospital PCMS and RC Karond Bypass Road Bhanpur Bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
7030091361 |
| Fax |
|
| Email |
Prince.brahme@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples Hospital Peoples College of Medical Sciences and Research Centre Karond Bypass Road Bhanpur Bhopal Madhya Pradesh 462037 |
|
|
Primary Sponsor
|
| Name |
Peoples Hospital |
| Address |
Peoples College of Medical Sciences and Research Centre Karond Bypass Road Bhanpur Bhopal Madhya Pradesh 462037 |
| 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 Pushpraj Brahme |
Peoples Hospital |
Room no 1 Department of Anaesthesia 1st floor Peoples College of Medical Sciences and Research Centre Karond Bypass Road Bhanpur Bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH |
7030091361
Prince.brahme@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PCMS & RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
10% lignocaine spray |
Patients will be give 2 puffs of 10% lignocaine spray in the dose of 10mg per puff oropharyngeally and will be assessed for 10 minutes |
| Intervention |
Nitroglycerine spray |
Patients will be given 2 puffs of Nitroglycerine spray in the dose of 400mcg per puff orally and will be assessed for 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Asa grade 1 and 2
Elective surgery under general anaesthesia with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Lack of patients consent
Age less than 18 years and more than 60 years
ASA grade 3 and more
Patient with anticipated difficult airway
Patient with hypersensitivity to any of the drugs used
Pregnant and lactating mothers
Hypertensive patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Attenuation of pressor response |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters |
10 minutes |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/08/2024 |
| 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
|
This is a postgraduate thesis to study the attenuation response of nitroglycerine spray and 10% lignocaine spray. This study comprises of 120 patients divided into 2 groups. One group will recieve Nitroglycerine spray and the other will receive lignocaine spray prior to laryngoscopy. The stress response during laryngoscopy will be recorded for 10 minutes and compared. |