| CTRI Number |
CTRI/2024/08/072996 [Registered on: 27/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| 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
|
Comparison of effect of Nitroglycerin spray with lignocaine spray and lignocaine spray alone on haemodynamic responses to laryngoscopy and endotracheal intubation |
|
Scientific Title of Study
|
Additive effect of nitroglycerine spray with lignocaine spray lignocaine spray alone on haemodynamic responses to laryngoscopy and endotracheal intubation a comparative 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 |
Vasioullah Khan |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
Department of Anaesthesiology, King Georges Medical University, Lucknow
Department of Anaesthesiology, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7906821058 |
| Fax |
|
| Email |
vasi.khan009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ajay Kumar Chaudhary |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Anaesthesiology, King Georges Medical University, Lucknow
Department of Anaesthesiology, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415022374 |
| Fax |
|
| Email |
ajaychaudhary62@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vasioullah Khan |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
Department of Anaesthesiology, King Georges Medical University, Lucknow
Department of Anaesthesiology, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7906821058 |
| Fax |
|
| Email |
vasi.khan009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, King Georges Medical University, Lucknow- 226003, India |
|
|
Primary Sponsor
|
| Name |
King Georges Medical University |
| Address |
Department of Anaesthesiology, KGMU, Lucknow |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ajay Kumar Chaudhary |
Department of Anaesthesiology, KGMU, Lucknow |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vasioullah Khan |
King Georges Medical University |
Department Of Anesthesia, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH |
917906821058
vasi.khan009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KGMU, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z428||Encounter for other plastic and reconstructive surgery following medical procedure or healed injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lignocaine (15%) |
Comparator: lignocaine 15% 2 puffs 1 minute before laryngoscopy and endotracheal intubation. Route sublingual.
Time period 1 year |
| Intervention |
Nitroglycerine 400ug |
Agent : nitroglycerine 400ug 1 puff + lignocaine 15% 2 puff 1 minute before laryngoscopy. Route sublingual |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who were classified as ASA grade I/II, had ages ranging between 18 to 60 years, were scheduled for elective surgeries under general anesthesia with endotracheal intubation, and provided written informed consent will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients who exhibited allergy to the study drug, anticipated difficult airways, required emergency surgical procedures, possessed a history of laryngeal or tracheal surgery or any related pathology, had pre-existing cardiac disease, hypertension, or chronic obstructive pulmonary disease (COPD), or refused to provide consent will be excluded from participation in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure and compare the effect of Nitroglycerine 400ug with lignocaine (15%) 2 puff and Lignocaine (15%) 2 puff alone on the hemodynamic responses to laryngoscopy and endotracheal intubation. |
• At intervals of 1, 3, 5, 10, and 15 minutes after laryngoscopy and tracheal intubation, the vital parameters will be monitored and compared. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the adverse effect of the Nitroglycerine 400ug with lignocaine (15%) 2 puff & Lignocaine (15%) 2 puff alone on the hemodynamic responses to laryngoscopy & endotracheal intubation. |
During & after laryngoscopy & tracheal intubation (Approximately 30 min) |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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 2 |
|
Date of First Enrollment (India)
|
13/09/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 prospective randomized controlled study is comparing the effects of Nitroglycerine 400ug with lignocaine (15%) 2 puff and Lignocaine (15%) 2 puff alone on the hemodynamic responses to laryngoscopy and endotracheal intubation. A total 124 patients will be enrolled as per inclusion-exclusion criteria. Patients will be divided randomly into two groups of 62 each. In group N, Nitroglycerine 400ug with lignocaine (15%) 2 puff will be sprayed and in group L, Lignocaine (15%) 2 puff will be sprayed before laryngoscopy and tracheal intubation. During surgery, the patient’s pulse rate, blood pressure, ECG, urine output, and blood loss will be monitored continuously. After the intubation, at intervals of 1, 3, 5, 10, and 15 minutes after laryngoscopy and tracheal intubation, the vital parameters will be monitored. Adverse effects will be noted for both groups separately and compared. |