| CTRI Number |
CTRI/2025/10/096724 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
26/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two drugs,sugammadex and neostigmine reversals in preventing the lung complications after surgery in COPD patients. |
|
Scientific Title of Study
|
Comparative evaluation of Sugammadex and Neostigmine reversals in preventing post-operative pulmonary complications in chronic obstuctive pulmonary disease - A Prospective , Randomized , Double blinded 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 |
S Sevukar Raja |
| Designation |
Assistant Professor |
| Affiliation |
Bhaarath Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Ground floor OT complex,
Hospital block,
Bhaarath Medical college and Hospital,
173, Agaram Main Road, Selaiyur, Chennai
Chennai
TAMIL NADU
600073
India |
| Phone |
9500976956 |
| Fax |
|
| Email |
drsevukar@live.in |
|
Details of Contact Person
Scientific Query
|
| Name |
S Sevukar Raja |
| Designation |
Assistant Professor |
| Affiliation |
Bhaarath Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Ground floor OT complex,
Hospital block,
Bhaarath Medical college and Hospital,
173, Agaram Main Road, Selaiyur, Chennai
Chennai
TAMIL NADU
600073
India |
| Phone |
9500976956 |
| Fax |
|
| Email |
drsevukar@live.in |
|
Details of Contact Person
Public Query
|
| Name |
S Sevukar Raja |
| Designation |
Assistant Professor |
| Affiliation |
Bhaarath Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Ground floor OT complex,
Hospital block,
Bhaarath Medical college and Hospital,
173, Agaram Main Road, Selaiyur, Chennai
Chennai
TAMIL NADU
600073
India |
| Phone |
9500976956 |
| Fax |
|
| Email |
drsevukar@live.in |
|
|
Source of Monetary or Material Support
|
| Bhaarath Medical college and Hospital
173, Agaram Main Road, Selaiyur, Chennai, Tamil Nadu 600073 |
|
|
Primary Sponsor
|
| Name |
S Sevukar Raja |
| Address |
Assistant Professor,
Department of Anaesthesiology,
Bhaarath Medical college and Hospital,
173, Agaram Main Road, Selaiyur, Chennai, Tamil Nadu 600073 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| N Gnanasekar |
Associate Professor,
Department of Anaesthesiology,
Bhaarath Medical college and Hospital,
173, Agaram Main Road, Selaiyur, Chennai, Tamil Nadu 600073 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Sevukar Raja |
Bhaarath Hospital |
Department of Anaesthesiology,
Ground floor OT complex,
Hospital block,
Bhaarath Medical college and Hospital,
173, Agaram Main Road, Selaiyur, Chennai-600073
Chennai
TAMIL NADU |
9500976956
drsevukar@live.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaarath Institutional Ethics Committee |
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 |
| Intervention |
Neostigmine |
Neostigmine (50mcg/kg) mixed with Glycopyrrolate (10mcg/kg) at the end of surgery for reversal from general anaesthesia |
| Comparator Agent |
Sugammadex |
Sugammadex (2mg/kg) at the end of surgery for reversal from general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
BMI 18-25kg/m2 , Patients scheduled for elective laparoscopic abdominal surgeries |
|
| ExclusionCriteria |
| Details |
History of allergy to the study drugs , Chronic renal disease patients ( creatinine clearance lesser than 30ml/min) , Patients with other co existing pulmonary diseases, Patients with severe coronary artery insufficiency and other fixed cardiac output states, Emergency surgeries , Moribund patients |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of peak expiratory flow rate in both the groups in the preoperative period and at varied time intervals post operatively |
Baseline peak expiratory flow rate value preoperatively , immediately following extubation , in hours till 6 hours post procedure then at 24 hours interval till post operative day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate the incidence of post operative pulmonary complications(PPC) like COPD exacerbation, inability to clear secretions, bronchospasm and respiratory failure in both the groups measured upto 3 days after the surgery |
Immediately following extubation , in hours till 6 hours post procedure then at 24 hours interval till post operative day 3 |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="0"
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
|
Chronic obstructive
pulmonary disease(COPD) poses specific threats in the post operative period
following general anaesthesia. Complications like hypoxemia, atelectasis,
pneumonia, inability to clear the secretions and respiratory failure are known
problems especially after abdominal surgeries.Laparoscopic
abdominal surgeries are safe & effective alternative when compared to open
procedures.Laparoscopic approach tend to reduce the
incidence of above mentioned complications in COPD patients when compared to open surgeries.Respiratory muscles
recovery following neuromuscular blockade in general anaesthesia plays a
significant role in contributing to the above mentioned complications in these
patients.Peak expiratory flow rate (PEFR)
measurement is a useful and effective bed side
tool to assess the severity
of airflow limitation in Chronic obstructive pulmonary disease (COPD)
patients.Traditionally,
reversing residual neuromuscular blockade was achieved with the use of
anticholinesterases like neostigmine which had some muscarinic side effects
apart from being non selective. Now a days selective neuromuscular reversal
agents like Sugammadex have been safely implicated in patients with
comorbidities and with low side effects.
The proposed study would aim to compare the efficacy
of Sugammadex and Neostigmine
using PEFR measurements in preventing post operative pulmonary
complications in COPD patients.
The present study is a prospective , single centered , double blinded study in patients undergoing elective laparoscopic abdominal surgeries of various specialities in Bhaarath medical college and hospital . The study would be carried out for 6 months duration.
The primary outcome of the study would be to measure the PEFR in both the groups
in the preoperative period and at varied time intervals post operatively.
Any incidence of post
operative pulmonary complications(PPC) like COPD exacerbation, inability to
clear secretions, bronchospasm and respiratory failure in both the groups
measured upto 3 days after the surgery would be chosen as secondary outcomes.
|