| CTRI Number |
CTRI/2024/05/068057 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between sugammadex and neostigmine for reversal of blockade in neurosurgery patients |
|
Scientific Title of Study
|
A Comparative Study of Sugammadex versus Neostigmine for Reversal of Vecuronium-Induced Neuromuscular Blockade Following Intracranial Tumor Resection
Surgery In Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Nayak |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research,Sawangi |
| Address |
Department Of Anaesthesia,Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research,Sawangi ,Wardha ,Maharastra ,PIN-442001
Department Of Anaesthesia,Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research,Sawangi ,Wardha ,Maharastra ,PIN-442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8249892501 |
| Fax |
|
| Email |
aishwarya291192@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Roshan Nisal |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia,Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research,Sawangi,Maharastra ,India
Department of Anaesthesia,Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research,Sawangi,Maharastra ,India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8249892501 |
| Fax |
|
| Email |
dr.roshannisal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Nayak |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia,Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research,Sawangi,Maharastra ,India
Department of Anaesthesia,Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research,Sawangi,Maharastra ,India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8249892501 |
| Fax |
|
| Email |
aishwarya291192@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research,Sawangi,Wardha ,Maharastra ,India ,PIN -442001 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical CollegeDatta Meghe Institute of Higher Education and Research |
| Address |
Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research ,Sawangi,Wardha ,Maharastra ,India ,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 Aishwarya Nayak |
Shalinitai Superspeciality Hospital |
Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research ,Sawangi,Wardha ,Maharastra ,442001
Wardha
MAHARASHTRA |
8249892501
aishwarya291192@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neostigmine |
Group N will be administered Neostigmine.
Dose -0.05mg/kg
frequency - once
route of adminstration -Intravenous
total duration of such intervention - 24hours |
| Intervention |
Sugammadex |
Group S will be administered Sugammadex .
Dose -2mg/kg
frequency - once
route of adminstration -Intravenous
total duration of such intervention - 24hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a. Inclusion Criteria:
1. Consenting adults, undergoing elective intracranial tumor surgery under general anaesthesia with Vecuronium-induced neuromuscular blockade.
2.Adult patient above age of 18yrs -65yrs
3.No comorbidity
4.GCS –15/15
|
|
| ExclusionCriteria |
| Details |
1.Patients with contraindications to Sugammadex or Neostigmine
2.Pre-existing neuromuscular disorders
3. Those requiring prolonged postoperative ventilation.
4.Malignant hyperthermia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time taken for the reversal of neuromuscular blockade
|
1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Incidence of residual neuromuscular blockade post-reversal.
3. Recovery of neuromuscular function assessed via train-of-four ratio or similar monitoring methods.
4. Safety outcomes: Respiratory events, hemodynamic instability, and occurrence of cholinergic side effects.
5. Emergence from anesthesia and time to extubation.
|
1 hour |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Introduction:Intracranial surgeries demand precise neuromuscular control to ensure optimal conditions and minimize patient movement. Traditional reversal agents like Neostigmine may have limitations, prompting the investigation of Sugammadex, which offers rapid and specific reversal of neuromuscular blockade induced by agents like Vecuronium.Objective: This study aims to compare the efficacy, safety, and speed of recovery between Sugammadex and Neostigmine in reversing Vecuronium-induced neuromuscular blockade following intracranial surgery.Methods: A prospective, randomized controlled trial will be conducted on adults undergoing intracranial tumor resection surgery. Patients will be randomly allocated to receive either Sugammadex (2mg/kg) or Neostigmine (0.05mg/kg) for neuromuscular blockade reversal. Various parameters including time to reversal, incidence of residual blockade, recovery of neuromuscular function, and safety outcomes will be assessed.Results: A total of 50 patients will be included, with 25 in each group. Primary outcomes include time taken for reversal of neuromuscular blockade, while secondary outcomes encompass residual blockade incidence, neuromuscular function recovery, and safety profiles.Conclusion: This study will provide valuable insights into the comparative efficacy and safety of Sugammadex and Neostigmine in reversing Vecuronium-induced neuromuscular blockade following intracranial surgery. Findings will contribute to optimizing anesthesia practices, enhancing patient outcomes, and minimizing postoperative complications in this critical surgical setting. |