| CTRI Number |
CTRI/2025/10/095799 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of Sugammadex and Neostigmine on Early Postoperative Respiratory Recovery in Elderly Patients |
|
Scientific Title of Study
|
Impact of reversal of neuromuscular blockade with Sugammadex vs Neostigmine on early postoperative respiratory muscle function in geriatric population |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amriish Garg |
| Designation |
Post graduate resident |
| Affiliation |
Himalayan Institute of Medical Sciences, Jolly Grant, Dehradun |
| Address |
Department of Anaesthesiology and Pain Management
Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Dehradun
Dehradun
UTTARANCHAL
248140
India |
| Phone |
8449636169 |
| Fax |
|
| Email |
amriish.ag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gurjeet Khurana |
| Designation |
Professor and Head |
| Affiliation |
Himalayan Institute of Medical Sciences, Jolly Grant, Dehradun |
| Address |
Department of Anaesthesiology and Pain Management
Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Dehradun
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9410539190 |
| Fax |
|
| Email |
gurjeetkhurana@srhu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Gurjeet Khurana |
| Designation |
Professor and Head |
| Affiliation |
Himalayan Institute of Medical Sciences, Jolly Grant, Dehradun |
| Address |
Department of Anaesthesiology and Pain Management
Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Dehradun
UTTARANCHAL
248140
India |
| Phone |
9410539190 |
| Fax |
|
| Email |
gurjeetkhurana@srhu.edu.in |
|
|
Source of Monetary or Material Support
|
| Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Dehradun, India, 248140 |
|
|
Primary Sponsor
|
| Name |
Himalayan Institute of Medical Sciences |
| Address |
Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Dehradun |
| Type of Sponsor |
Private medical college |
|
|
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 Amriish Garg |
Himalayan Institute of Medical Sciences |
Department of Anaesthesiology and Pain Management
Himalayan Institute of Medical Sciences, first floor, Swami Rama Himalayan University, Jolly Grant, Dehradun
Dehradun
UTTARANCHAL |
8449636169
amriish.ag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Himalayan Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M96-M96||Intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Neostigmine |
0.05mg/kg intravenous single dose after completion of surgery prior to extubation |
| Comparator Agent |
Injection Sugammadex |
2mg/kg intravenous single dose after completion of surgery prior to extubation |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiologist Physical Status I-III
2. Scheduled for a surgical procedure under general anaesthesia requiring endotracheal intubation
3. Anaesthesia induction with Vecuronium as NMBA |
|
| ExclusionCriteria |
| Details |
1. Anticipation of a difficult airway
2. Known or suspected neuromuscular disorders, significant renal dysfunction, known or suspected family history of malignant hyperthermia, and allergies to narcotics, muscle relaxants, or other medications used during general anaesthesia
3. Patients receiving medication at a dose and/or time-point likely to interfere with NMBDs and in whom the use of Neostigmine and/or glycopyrrolate could be contraindicated
4. Those with diaphragm insufficiency or massive pleural effusion
5. Those undergoing upper abdominal laparotomy will be excluded after which we cannot obtain a satisfactory ultrasound imaging or do not have space for the placement of the ultrasound probe |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative Pulmonary function after neuromuscular blockade reversal associated with the use of Sugammadex and Neostigmine |
10,30,60 and 120 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the residual neuromuscular blockade effect of Vecuronium after reversal with Sugammadex compared to Neostigmine up to 2 hours postoperatively. |
10,30,60 and 120 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/10/2025 |
| 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)
|
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
|
This study is a comparative observational analysis evaluating the effectiveness of Sugammadex versus Neostigmine in reversing Vecuronium-induced neuromuscular blockade in patients aged over 65 years undergoing surgery under general anaesthesia. It aims to assess postoperative pulmonary function and residual blockade using spirometry, train-of-four monitoring, and diaphragm ultrasonography up to two hours postoperatively.
The study includes 100 patients, divided equally into two groups receiving either Sugammadex 2 mg/kg or Neostigmine 0.05 mg/kg with glycopyrrolate. Parameters such as inspiratory volume, TOF ratio, diaphragm contractility, and clinical recovery indicators are measured at set intervals post-reversal. The goal is to determine which agent ensures faster and more complete recovery with fewer respiratory complications, especially in the elderly.
|