| CTRI Number |
CTRI/2025/07/091152 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on How Well Sugammadex and Neostigmine Help Muscles Recover After Surgery under general anaesthesia Using Muscle Relaxants |
|
Scientific Title of Study
|
A COMPARATIVE STUDY ON EFFECTIVENESS OF SUGAMMADEX AND NEOSTIGMINE IN REVERSING VECURONIUM AND CISTARACURIUM INDUCED NEUROMUSCULAR BLOCK |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PAUL VARGHESE |
| Designation |
Junior Resident |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anesthesiology
Amala Institute of Medical Sciences,Thrissur
Amala Institute of Medical Sciences, Amala nagar,Thrissur
Thrissur
KERALA
680555
India |
| Phone |
9591579534 |
| Fax |
|
| Email |
paulvarghese97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mithun P Raju |
| Designation |
Associate Professor and Guide |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Amala Institute of Medical Sciences, Thrissur
Thrissur
KERALA
680555
India |
| Phone |
9961738780 |
| Fax |
|
| Email |
mithunraju@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lini Chacko |
| Designation |
Associate Professor and co-guide |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Amala Institute of Medical Sciences,
Thrissur
Thrissur
KERALA
680555
India |
| Phone |
9496387762 |
| Fax |
|
| Email |
drpclini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr.Paul Varghese |
| Address |
Junior Resident in Department of Anesthesiology, Amala Institute of Medical Sciences,Thrissur |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrPaul Varghese |
Amala Institute of Medical Sciences |
Operation theaters
Department of Anesthesiology
Thrissur
KERALA |
95915 79534
paulvarghese97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Amala Institute of Medical Sciences |
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 |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anesthesiologists (ASA) I / II.
2.Elective surgery under general anesthesia
3.Mallampatti Grades of I and II
|
|
| ExclusionCriteria |
| Details |
1.Patients with a history of drug allergy to any of the studied drugs
2.Patients with difficulty in communication and pregnancy
3.Patients with significant neurologic, psychiatric, hepatic, renal or cardiac disease.
4.Morbid obesity (BMI more than 40)
5.a history of recent respiratory tract infection or sore throat anticipated difficult airway
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the efficacy of sugammadex in the reversal of vecuronium induced neuromuscular block among patients receiving general anesthesia
2.To study the efficacy of neostigmine in the reversal of cisatracurium induced neuromuscular block among patients receiving general anesthesia
3.To compare the efficacy of sugammadex in the reversal of vecuronium induced neuromuscular block and neostigmine in reversal of cisatracurium induced neuromuscular block among patients receiving general anesthesia
|
TOF ratio at 0,1,2,3,4,5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
25/07/2025 |
| 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="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
|
This study is an observational study comparing the effectiveness of Sugammadex versus Neostigmine in reversing neuromuscular block induced by Vecuronium and Cisatracurium, respectively, in adult patients undergoing elective surgeries under general anaesthesia. The primary objective is to assess the time taken to achieve a TOF ratio more than or equal to 0.9 using acceleromyography, along with evaluation of immediate postoperative recovery. |