| CTRI Number |
CTRI/2024/11/076218 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing how often breathing issues occur during and after surgery when using two drugs, sugammadex and neostigmine, after sinus surgery |
|
Scientific Title of Study
|
To compare the frequency of perioperative respiratory adverse events using sugammadex versus neostigmine following functional endoscopic sinus surgery |
| 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 Gaganjot Kaur |
| Designation |
Associate Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
8198014504 |
| Fax |
|
| Email |
drgaganjot@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaganjot Kaur |
| Designation |
Associate Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
8198014504 |
| Fax |
|
| Email |
drgaganjot@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mandeep Saini |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9465683383 |
| Fax |
|
| Email |
sainihsp22@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Sri Guru Ram Das Institute of Medical
Sciences and Research, Mehta Road, Vallah 143001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ruchi Gupta |
Operation Theatre |
OT no-5, Main OT,Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB |
09814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD Ethical 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 |
| Comparator Agent |
Reversal agent |
Neostigmine 0.05mg/kg + Glycopyrrolate 0.4mg
intravenous at the time of Extubation
|
| Intervention |
Reversal agent |
Sugammadex 4mg/kg intravenous, At the time of extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA physical status I and II
2.Patients undergoing functional endoscopic sinus surgery |
|
| ExclusionCriteria |
| Details |
1.Known hypersensitivity to study drugs
2. History of any Respiratory disorder or Respiratory Tract Infection
3. History of drug abuse or Smoking
4. Serum creatinine more than 1.5 mg per dl
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of the study is to assess the frequency of
Perioperative respiratory adverse events following Functional Endoscopic Sinus
Surgery.
|
at the time of extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to recovery of neuromuscular function
2. Hemodynamic Variation
3. Post-operative complications, if any. |
after extubation till 30 min |
|
|
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)
|
08/11/2024 |
| 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 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 - NO
|
|
Brief Summary
|
Introduction : Functional endoscopic sinus surgery (FESS) is a common procedure for
managing sinus disorders, including chronic rhinosinusitis. Successful FESS not only
relies on surgical technique but also on postoperative recovery, particularly
neuromuscular function restoration and airway protection. Residual Neuromuscular
Blockade (NMB) poses risks like airway obstruction and hypoxia, emphasizing the need
for faster recovery. Sugammadex accelerates NMB reversal, reducing the risk of residual
paralysis compared to neostigmine. This study aims to compare perioperative adverse
events post-NMB reversal with sugammadex versus neostigmine in FESS patients.
Aim: To compare the frequency of Perioperative respiratory adverse events (PRAE) using
sugammadex or neostigmine as neuromuscular reversing agent following Functional
Endoscopic Sinus Surgery (FESS).
Objectives: To calculate and compare the frequency of Perioperative respiratory adverse
events, Time to recovery of neuromuscular function and Hemodynamic Variation using
sugammadex or neostigmine as a reversal agent after FESS surgery.
Methodology : This randomized, controlled, prospective, double-blinded study will be
conducted in 70 patients (aged 20-70 years) scheduled for Functional Endoscopic Sinus
Surgery. The patients will be randomly allocated into two groups (35 patients each) to
receive neuromuscular blockade reversal agent accordingly - Group A: Sugammadex 4
mg/kg intravenous; Group B: Neostigmine 0.05mg/kg + Glycopyrrolate 0.4mg
intravenous. The frequency of Perioperative respiratory adverse events, time to recovery
of neuromuscular function and hemodynamic variations will be noted and compared in
the two groups.
Significance of the study : This study seeks to enhance neuromuscular blockade reversal
in Functional Endoscopic Sinus Surgery (FESS) by comparing Sugammadex and
Neostigmine, crucial for patient safety and surgical success. Assessing their effectiveness,
reversal speed, residual blockade incidence, and safety profile is vital for informed clinical
decisions and better patient outcomes. |