| CTRI Number |
CTRI/2025/11/097066 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
ASSESSMENT OF AWAKENING FROM ANAESTHESIA FOLLOWING SUGAMMADEX ADMINISTRATION AS A REVERSAL AGENT |
|
Scientific Title of Study
|
An Observational Study on Emergence from Anaesthesia in Adults Following Sugammadex Administration as a Neuromuscular Blockade Reversal Agent |
| 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 M Venkat karli |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical care, K S Hegde medical academy, P.O Nithyananda nagar, Mangalore, Karnataka
Department of Anaesthesiology and Critical care, K S Hegde medical academy, boys hostel, Nithyananda nagar, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09036765473 |
| Fax |
NA |
| Email |
venkatkarli51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Murali Shankar Bhat A |
| Designation |
ASSOCIATE PROFFESOR |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical care, K S Hegde medical academy, P.O Nithyananda nagar, Mangalore, Karnataka
Department of Anaesthesiology and Critical care, K S Hegde medical academy, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8884537753 |
| Fax |
NA |
| Email |
muralishankarbhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR M Venkat karli |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical care, K S Hegde medical academy, P.O Nithyananda nagar, Mangalore, Karnataka
Department of Anaesthesiology and Critical care, K S Hegde medical academy, boys hostel, Nithyananda nagar, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09036765473 |
| Fax |
Nil |
| Email |
venkatkarli51@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical academy Deralakatte Mangalore Karnataka- 575018 |
|
|
Primary Sponsor
|
| Name |
K S HEGDE MEDICAL ACADEMY |
| Address |
Department of Anaesthesiology and Critical care, K S Hegde medical academy, P.O Nithyananda nagar, Mangalore, Karnataka |
| 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 M Venkat karli |
KS Hegde Medical academy |
Department of Anaesthesiology and Critical Care KS Hegde Medical academy P O Nithyananda nagar Mangalore-575018
Dakshina Kannada
KARNATAKA |
9036765473
venkatkarli51@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE, K S Hegde Medical Academy |
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-60 years
ASA-PS I and II
Expected surgical duration less than 3 hours
Patients undergoing elective surgeries |
|
| ExclusionCriteria |
| Details |
1.Patient who cannot comprehend, uncooperative patient
2.Neuropsychiatric disease
3.Chronic alcohol or drug addict
4.Planned postoperative ICU Admission |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare recovery status in the postoperative period following reversal from general anaesthesia using Sugammadex and Neostigmine, using
1.AVPU scale
2.six screener test
3.MiniCog test |
To compare recovery status in the postoperative period following reversal from general anaesthesia using Sugammadex and Neostigmine, using
1.AVPU scale
2.six screener test
3.MiniCog test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Nil |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study focuses on evaluating the effectiveness and timeline of patient awakening status after general anaesthesia when sugammadex is used as a neuromuscular blockade reversal agent. Sugammadex, a modified gamma cyclodextrin, is specifically designed to reverse the effects of steroidal neuromuscular blocking agents, such as rocuronium and vecuronium. The research assesses parameters such as time to return of spontaneous respiration, eye opening, ability to follow verbal commands, and extubation readiness. It also compares the recovery profile of sugammadex with traditional reversal agents like neostigmine, aiming to determine its safety, efficacy, and potential benefits in improving post-anaesthesia recovery.
|