| CTRI Number |
CTRI/2025/09/094367 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Check clinical efficacy of two different doses of intranasal nitroglycerine spray to attenuation of haemodynamic stress response to pneumoperitoneum in laparoscopic surgeries A prospective randomised study |
|
Scientific Title of Study
|
A Prospective Randomised Study to Evaluate the Efficacy of Two Different Doses of Intranasal Nitroglycerine Spray in Attenuating Haemodynamic Stress Response to Pneumoperitoneum during Laparoscopic Surgeries |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Maina Singh |
| Designation |
Professor |
| Affiliation |
Department of anesthesiology in jln medical College ajmer rajasthan |
| Address |
Department of anesthesiology in jln medical College ajmer rajasthan
Jln medical College ajmer rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414097045 |
| Fax |
|
| Email |
mainasingh111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Maina Singh |
| Designation |
Professor |
| Affiliation |
Department of anesthesiology in jln medical College ajmer rajasthan |
| Address |
Department of anesthesiology in jln medical College ajmer rajasthan
Jln medical College ajmer rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414097045 |
| Fax |
|
| Email |
mainasingh111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MAINA SINGH |
| Designation |
PROFESSOR |
| Affiliation |
DEPARTMENT OF ANAESTHESIA JLN MEDICAL COLLEGE AJMER |
| Address |
DEPARTMENT OF ANAESTHESIA JLN MEDICAL COLLEGE AJMER RAJASTHAN
JLN MEDICAL COLLEGE AJMER RAJASTHAN
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414097045 |
| Fax |
|
| Email |
mainasingh111@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Maina Singh |
| Address |
Department of anesthesiology in jln medical College ajmer rajasthan
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Komal |
Jln medical College ajmer rajasthan |
| Dr Mohit Gurjar |
Jln medical College ajmer rajasthan |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Samay Singh Bainsala |
Jln medical College ajmer rajasthan |
Kalan bagh Ajmer Rajasthan
Ajmer
RAJASTHAN |
09414963329
mainasingh111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jln medical College ajmer rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vitals stable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
all adult patients of either 18 to 65 years Here a suitable Inclusion Criteria section for my trial in CTRI formet
Inclusion Criteria
1. Adult patients aged 18 to 65 years.
2. ASA Physical Status I–II.
3. Scheduled for elective laparoscopic abdominal surgery ( cholecystectomy appendicectomy diagnostic laparoscopy) under general anaesthesia.
4. Duration of surgery expected to be less than 2 hours.
5. Ability to provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
patient refusal
patient with known allergies to study medication
patient with uncontrolled hypertension perioperative bradycardia (heart and renal disease)
patient on chronic opioid or alpha2-adrenergic agonist or antagonist therapy
pregnant or lactating |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome Measure: Change in haemodynamic parameters – Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Arterial Pressure (MAP) – from baseline following induction of anaesthesia and during pneumoperitoneum.
|
From baseline (pre-induction) up to 15 minutes after creation of pneumoperitoneum.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [samaysingh634@gmail.com].
- For how long will this data be available start date provided 28-10-2024 and end date provided 15-09-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
---
Brief Summary
Laparoscopic surgeries require creation of pneumoperitoneum, which frequently produces sympathetic stimulation leading to tachycardia, hypertension, and increased myocardial oxygen demand. Such haemodynamic stress responses may be detrimental, especially in high-risk patients. Nitroglycerine, a nitric oxide donor and vasodilator, has a rapid onset of action when administered intranasally and may blunt these responses effectively.
The present prospective, randomised study is designed to evaluate the efficacy of two different doses of intranasal nitroglycerine spray in attenuating the haemodynamic stress response to pneumoperitoneum during laparoscopic surgeries under general anaesthesia. Patients will be randomised into two groups to receive one of the two test doses prior to pneumoperitoneum. Haemodynamic parameters including heart rate, systolic, diastolic and mean arterial pressures will be recorded at defined time-points and compared between groups.
|