| CTRI Number |
CTRI/2025/03/083118 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the time taken for reversal of neuromuscular
blockade in patients undergoing general anaesthesia with either sugammadex or sugammadex in combination with neostigmine |
|
Scientific Title of Study
|
Comparison of sugammadex and sugammadex combined with neostigmine for reversal of vecuronium induced neuromuscular blockade in patients undergoing general anaesthesia : A randomised clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANELLIA DARI I KA MASSAR |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences
Imphal
Imphal West MANIPUR 795004 India |
| Phone |
9508216498 |
| Fax |
|
| Email |
anelliad@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Y Arunkumar Singh |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences
Imphal
Imphal West MANIPUR 7950004 India |
| Phone |
9862282518 |
| Fax |
|
| Email |
yaks48@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Y Arunkumar Singh |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences
Imphal
Imphal West MANIPUR 7950004 India |
| Phone |
9862282518 |
| Fax |
|
| Email |
yaks48@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Imphal West Manipur
795004
India |
|
|
Primary Sponsor
|
| Name |
Anellia Dari I Ka Massar |
| Address |
Regional Institute of Medical Sciences, Imphal, Imphal West Manipur
795004
India |
| Type of Sponsor |
Other [Post Graduate Trainee] |
|
|
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 |
| Anellia Dari I Ka Massar |
Regional Institute of Medical Sciences, Imphal, Imphal West, Manipur 795004 India |
Elective surgery
Operation theatre
complex (OT 1-8)
Department of Anaesthesiology,
Regional Institue of Medical Sciences, Imphal
Imphal West
Manipur
795004
India
Imphal West MANIPUR |
9508216498
anelliad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, Regional Institute of Medical Sciences, Imphal, Manipur |
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 |
Sugammadex |
Group A will receive sugammadex at a dose of 2 mg/kg through intravenous route of administration as a single bolus dose at the end of the surgery for reversal of vecuronium-induced neuromuscular blockade when the two twitches to train of four stimulation appear in the TOF watch |
| Comparator Agent |
Sugammadex, neostigmine and glycopyrrolate combination |
Group B will receive a combination of sugammadex 1 mg/kg with neostigmine 50 mcg/kg and glycopyrrolate 10 mcg/kg through intravenous route of administration as a single bolus dose at the end of the surgery for reversal of vecuronium-induced neuromuscular blockade when the two twitches to train of four stimulation appear in TOF watch |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 to 60 years of either gender – male or female.
2. Patients with American Society of Anaesthesiologists (ASA) physical status Grade I to Grade II.
|
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal.
2. Patients with suspected difficult airway.
3. Patients with body mass index (BMI) more than 30 kg/m2.
4. Patients with known allergy to sugammadex, neostigmine and vecuronium.
5. Patients with pre-existent clinical conditions like chronic obstructive pulmonary disease, severe renal dysfunction, hepatic disease, cardiovascular disease, neurodegenerative disease and neuromuscular disease.
6. Pregnant or breastfeeding patients. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The time (in minutes) taken from the start of administration of the study drug (sugammadex or sugammadex combined with neostigmine) to the appearance of second twitch of train of four stimulation till recovery of normalised TOF ratio of 0.9 or more. |
Outcome will be measured in a single time point, i.e. from the point of administration of study drug (baseline),till attainment of train of four ratio of 0.9 . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameters like Blood pressure, pulse rate, spo2, heart rate & also any adverse effects like bradycardia, tachycardia, hypotension, anaphylaxis, nausea
or vomiting.
|
Secondary outcomes will be measured from baseline that is at the time of administration of study drug. After that,it will be measured every 10 minutes thereafter till immediate postoperative period for upto 1 hour. |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
30/04/2025 |
| 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="2" 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
|
The use of neuromuscular blocking agents during induction of anaesthesia, facilitates intubation and improve surgical access by providing muscle relaxation and maintaining deep neuromuscular blockade until the end of the operation. Rapid reversal of neuromuscular blockade at the end of surgery is desirable to enhance patient safety and to avoid post operative complications like residual neuromuscular blockade. Sugammadex is a novel agent without cholinergic side effects that specifically binds to steroidal neuromuscular blocking agents like vecuronium and rocuronium, reversing their effects and thus, rapidly restoring neuromuscular function. The use of sugammadex along with neostigmine can enhance neuromuscular recovery, thereby allowing for a lower dosage of sugammadex to be administered. By reducing the dosage of sugammadex, it can lower the overall cost of sugammadex while its efficacy is preserved. Hence, in this study we want to compare sugammadex and sugammadex combined with neostigmine for reversal of vecuronium induced neuromuscular blockade in patients undergoing general anaesthesia. After obtaining ethical clearance and written informed consent, a total number of 120 patients between 18-60 years of ASA physical status I and II undergoing elective surgery under general anaesthesia in the Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur will be randomly divided into two groups of 60 each. Group A patients will receive sugammadex at a dose of 2 mg/kg and Group B patients will receive a combination of sugammadex 1 mg/kg with neostigmine 50 mcg/kg and glycopyrrolate 10 mcg/kg for reversal of vecuronium induced neuromuscular blockade when two twitches to train of four stimulation appear. After administration of reversal agent, the time taken from the start of administration of the study drugs to the appearance of second twitch of train of four stimulation till recovery of its normalised ratio of 0.9 will be compared between the two groups. Additionally, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), oxygen saturation (SpO2) and heart rate (HR) will be recorded. All the findings and observations made during the entire study will be recorded in a proforma, tabulated in the EXCEL software and statistically analysed using SPSS software. Inference will be drawn to evaluate and compare the study drugs along with their clinical advantages and adverse effects. |