| CTRI Number |
CTRI/2025/09/095229 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the reversal of vecuronium induced neuromuscular blockade using sugammadex 100mg and neostigmine 2.5mg in surgery under general anaesthesia. |
|
Scientific Title of Study
|
Comparison of reversal of vecuronium induced
neuromuscular blockade using sugammadex 100mg and neostigmine 2.5mg in surgery under general anaesthesia. |
| 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 Avnish Kaur Saluja |
| Designation |
Junior resident |
| Affiliation |
Datta meghe institute of higher education and research |
| Address |
Department of Anaesthesiology , Jawaharlal Nehru Medical College, sawangi meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9521420339 |
| Fax |
|
| Email |
salujaavnishkaur@gmail.con |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjot Ninave |
| Designation |
Professor |
| Affiliation |
Datta meghe institute of higher education and research |
| Address |
Department of Anaesthesiology , Jawaharlal Nehru Medical College, sawangi meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9921213404 |
| Fax |
|
| Email |
drsusann02@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjot Ninave |
| Designation |
Professor |
| Affiliation |
Datta meghe institute of higher education and research |
| Address |
Department of Anaesthesiology , Jawaharlal Nehru Medical College, sawangi meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9921213404 |
| Fax |
|
| Email |
drsusann02@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College , Sawangi Meghe, Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Sawangi meghe, wardha, 442001 |
| 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 Avnish Kaur Saluja |
Jawaharlal Nehru Medical College |
Department of Anaesthesiology, JNMC, sawangi meghe, wardha
Wardha
MAHARASHTRA |
9521420339
salujaavnishkaur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of higher education and research, Deemed to be university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M279||Disease of jaws, unspecified, (2) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neiostigmine |
Inj. Neostigmine 2.5mg intravenously for reversal after general anaesthesia |
| Intervention |
Sugammadex |
Inj. Sugammadex 100mg intravenously for reversal after general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I,II, III
Patients willing to participate in the study
Prolonged duration surgery under general anaesthesia for more than four hours.
Preoperative oxygen saturation of 98-100 percent on room air. |
|
| ExclusionCriteria |
| Details |
Lack of valid informed written consent.
ASA grade IV.
Patients with bleeding disorders.
Patients on anticoagulants.
Allergies to food and drugs.
Patients with cardiac, renal, hepatic and respiratory co-morbidities.
Patients on medication known to interact with neuromuscular blocking drugs e.g.: Antibiotics
(aminoglycosides, tetracycline), antidepressants, anticonvulsants, antiarrhythmics (calcium channel blockers and quinidine) and magnesium sulphate and patients with known allergy to
cisatracurium. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time of complete recovery (TOF=0.9) from vecuronium induced shallow neuromuscular blockade following administration of sugammadex 100mg with neostigmine 2.5mg on reversal to muscle relaxant. |
2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the number of patients requiring top-up doses of respective reversal agent to reach a Train-of-Four (TOF) ratio of more than equal to 0.9 in both groups.
2 . To compare the incidence of residual neuromuscular blockade, recurarization and any adverse effects associated between two groups.
3. To compare hemodynamic effects (e.g., heart rate, blood pressure) following administration of
each dose. |
2 hours |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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 |
|
Date of First Enrollment (India)
|
13/10/2025 |
| 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
|
Neuromuscular blocking agents are essential to ensure optimal surgical conditions during general
anesthesia. Sugammadex, a selective binding agent, is widely used to reverse neuromuscular
blockade. While weight-based dosing (2 mg/kg for shallow blockade) is recommended, many
clinicians administer a fixed dose of 100 mg in clinical practice. Other option is the use of
neostigmine 2.5mg for reversal of neuromuscular blockade. This study aims to compare efficacy
of reversal using sugammadex 100mg with neostigmine 2.5mg after surgery in General
Anaesthesia.
|