| CTRI Number |
CTRI/2024/06/068258 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing sugammadex and neostigmine for rapid and smooth recovery from anesthesia in intracranial lesion. |
|
Scientific Title of Study
|
A comparison of sugammadex and neostigmine for rapidity and smoothness of reversal of neuromuscular blockade in patient undergoing excision of intracranial space-occupying lesions. A prospective randomized, double-blind, single-center study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| G1K4/2024 Version 1.0 Dated 15 Feb 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gayatri Kumari |
| Designation |
Consultant Department of Neuroanesthesia and Neurocritical Care |
| Affiliation |
Life Line Hospital and Research Centre, Azamgarh |
| Address |
3rd Floor, Department of Neuroanesthesia and Critical care , Room No. 1, Life Line Hospital and Research Centre,496- Madya
, Azamgarh, Uttar Pradesh India, Pin Code- 276001
Azamgarh
UTTAR PRADESH
276001
India |
| Phone |
9451243071 |
| Fax |
|
| Email |
reply2gayatri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Kumari |
| Designation |
Consultant Department of Neuroanesthesia and Neurocritical Care |
| Affiliation |
Life Line Hospital and Research Centre, Azamgarh |
| Address |
3rd Floor, Department of Neuroanesthesia and Critical care , Room No. 1, Life Line Hospital and Research Centre,496- Madya
, Azamgarh, Uttar Pradesh India, Pin Code- 276001
Azamgarh
UTTAR PRADESH
276001
India |
| Phone |
9451243071 |
| Fax |
|
| Email |
reply2gayatri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Kumari |
| Designation |
Consultant Department of Neuroanesthesia and Neurocritical Care |
| Affiliation |
Life Line Hospital and Research Centre, Azamgarh |
| Address |
3rd Floor, Department of Neuroanesthesia and Critical care , Room No. 1, Life Line Hospital and Research Centre,496- Madya
, Azamgarh, Uttar Pradesh India, Pin Code- 276001
Azamgarh
UTTAR PRADESH
276001
India |
| Phone |
9451243071 |
| Fax |
|
| Email |
reply2gayatri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Life Line Hospital and Research Centre,496- Madya
District- Azamgarh, Uttar Pradesh India, Pin Code- 276001 |
|
|
Primary Sponsor
|
| Name |
Life Line Hospital and Research Centre |
| Address |
496
Madya
Azamgarh,Uttar Pradesh , 276001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Gayatri Kumari |
Life Line Hospital and Research Centre Azamgarh |
OT 1 and OT 2
Department of Neuroanesthesia and Critical Care
Life Line Hospital and Research Centre
Azamgarh
UTTAR PRADESH |
9415243071
reply2gayatri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Life Line Hospital Azamgarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neostigmine Methyl sulphate |
Neostigmine Methyl sulphate 0.05mg/kg will be injected intravenous once over 10 seconds for reversal of neuromuscular blockade of Vecuronium Bromide based on train of four ratio 0.8 |
| Intervention |
Sugammadex |
Sugammadex 2mg/kg will be injected intravenous once over 10 seconds for reversal of neuromuscular blockade of Vecuronium Bromide based on train of four ratio 0.8 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Elective Craniotomies pertaining to Intracranial space occupying lesions
2. ASA II to III |
|
| ExclusionCriteria |
| Details |
1. Refusal to consent
2. Pediatric age group
3. Allergies to Study Drug
4. Neuro-degenerative, neuromuscular disorders
5. Pregnancy
6. Emergency surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of rapidity of reversal from neuromuscular blockade by using Sugammadex versus Neostigmine based on train of four ratio 0.8 |
Starting from administration of reversal agent till extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing hemodynamic events after reversal with sugammadex versus neostigmine |
till two hour after extubation |
| Secondary complication after reversal with sugammadex versus neostigmine |
Till two hours after extubation |
| Comparison of recovery from neuromuscular blockade using sugammadex versus neostigmine |
Time taken to achieve modified Aldrete score of 9/10 after extubation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/06/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
During reversal from the neuromuscular agent at the end of the surgery, hypertension, coughing, and bucking are avoided while the patient remains on the endotracheal tube because they can cause intracranial bleeding or a rise in ICP. The longer duration of recovery time increases these risks. Scondarily, It is essential to have the neurosurgical patient awake and responsive after surgery, allowing early neurologic assessment. This study is a randomized, double-blind, parallel, single-center comparing the rapid and smooth recovery of neuromuscular blockade using Sugammadex versus Neostigmine in 100 adult patients undergoing elective craniotomies. The primary outcome measures time is taken from administrating the reversal agent based on a train of four ratio of 0.8 to extubation. It also includes the additional anesthetic adjuvents used for smooth recovery. The secondary outcome measures the time taken for the modified Aldrete score to reach 9/10 after extubation, hemodynamic events, and complications until 1 hour from administrating the reversal agent. |