| CTRI Number |
CTRI/2025/02/080198 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF TWO DRUGS NEBULIZATION IN REDUCING HEART RATE AND BLOOD PRESSURE RESPONSE TO PNEUMOPERITONIUM DURING SHORT DURATION GYNEACOLOGICAL LAPAROSCOPIC SURGERIES |
|
Scientific Title of Study
|
COMPARISON OF LIGNOCAINE VS DEXMEDETOMIDINE NEBULIZATION IN ATTENUATING PRESSOR RESPONSE TO PNEUMOPERITONIUM DURING SHORT DURATION GYNEACOLOGICAL LAPAROSCOPIC SURGERIES -A DOUBLE BLIND RANDOMIZED COMPARATIVE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SAINATH T |
| Designation |
MD student |
| Affiliation |
Mahatma Gandhi medical College and research institute |
| Address |
Department of Anesthesiology, Mahatma Gandhi Medical College and Research Institute, SBV Pondicherry Campus, Pillayarkuppam, Puducherry Pondicherry,India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8500047800 |
| Fax |
|
| Email |
sainathsuniverse@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GAYATRI MISHRA |
| Designation |
Professor and guide |
| Affiliation |
Mahatma Gandhi medical College and research institute |
| Address |
Department of Anesthesiology, Mahatma Gandhi Medical College and Research Institute, SBV Pondicherry Campus, Pillayarkuppam, Puducherry Pondicherry India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894354068 |
| Fax |
|
| Email |
drgayatrimishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GAYATRI MISHRA |
| Designation |
Professor and guide |
| Affiliation |
Mahatma Gandhi medical College and research institute |
| Address |
Department of Anesthesiology, Mahatma Gandhi Medical College and Research Institute, SBV Pondicherry Campus, Pillayarkuppam, Puducherry Pondicherry India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894354068 |
| Fax |
|
| Email |
drgayatrimishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute, SBV Pondicherry campus, Pillaiyarkuppam, Puducherry- 607402, India |
|
|
Primary Sponsor
|
| Name |
Dr SAINATH T |
| Address |
Mahatma Gandhi Medical College and Research Institute, SBV Pondicherry campus, Pillaiyarkuppam, Puducherry- 607402, India |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr GAYATRI MISHRA |
Mahatma Gandhi Medical College and Research Institute, SBV Pondicherry campus, Pillaiyarkuppam, Puducherry- 607402, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sainath T |
Mahatma Gandhi medical college and research institute |
Department of Anesthesiology, A Block, second floor
Pondicherry
PONDICHERRY |
8500047800
sainathsuniverse@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee of Mahatma Gandhi Medical College and Research Institute, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NEBULIZATION 4% LIGNOCAINE |
Patient will be started on 1.5mg/kg body weight of 4% Lignocaine nebulization diluted in 0.9% NaCl solution to make total volume of 5ml for 20mins, for a duration of 15 months from IHEC approval |
| Comparator Agent |
NEBULIZATION DEXMEDITOMEDINE |
Patient will be started on neb Dexmedetomidine at a dose of 1mcg/kg body weight diluted in 0.9% NaCl solution making total volume of 5ml for 20 mins, for a duration of 15 months from IHEC approval |
| Intervention |
NEBULIZATION WITH 4% LIGNOCAINE OR DEXMEDITOMEDINE |
Patient will be started on nebulization of either mentioned drugs for over 20 mins after noting baseline hemodynamic, for a duration of 15 months from IHEC approval |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. American society of anesthesiologists patient status (ASA PA) 1 and 2
2. Surgery duration less than 3 hours |
|
| ExclusionCriteria |
| Details |
1. emergency cases
2. patients with decreased autonomic control such as uncontrolled diabetic patients
3. Anosmia, allergic rhinitis
4. patients with preoperative hypotension, bradycardia, dysrhythmia, severe cardiac diseases, complete heart block
5. patient with sinus bradycardia with HR lessthan 50/min, patient taking beta blockers, hepatic or renal dysfunction, obese patients with (BMI more than 30kg/sq meter)
6. patients with history of sleep apnea
7. Known allergy to either of the study drug will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure and compare the mean arterial pressure variation due to pneumoperitoneum between the two study groups. |
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To measure and compare the heart rate, blood presure variation due to pneumoperitoneum between the two study groups
2. To compare the intra operative opioid requirement in the two study groups.
3. To measure and compare recovery time in the two study groups.
4.To compare the post operative pain scores using VNRS score in the two groups. |
15 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
26/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/02/2025 |
| 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 randomised double blinded trail comparing pressor response attenuation efficiency of nebulization 4% lignocaine and nebulization dexmeditomedine in patients undergoing short duration laparoscopic surgery in 66 patients who are ASA 1 and ASA 2 physical status for the duration of 15 months. This study will be conducted in Mahatma Gandhi medical College and research institute, pondicherry, India. Primary outcome - to measure and compare mean arterial pressure variations due to pneumoperitonium between two study groups. Secondary outcome - To measure and compare intra op heart rate, blood pressure, opioid requirement and post operative pain score variations between two study groups. |