| CTRI Number |
CTRI/2025/08/093752 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of reversal time characteristics using full dose with two step administration
of Neostigmine for antagonizing Atracurium induced moderate block using
neuromuscular monitor –Double blinded randomized control trial
|
|
Scientific Title of Study
|
Assessment of reversal time characteristics using full dose with two step administration
of Neostigmine for antagonizing Atracurium induced moderate block using
neuromuscular monitor .A Double blinded randomized control 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 |
Mahalakshmi M |
| Designation |
MD Anaesthesia |
| Affiliation |
Pondicherry Institute of Medical sciences |
| Address |
Pondicherry Institute of Medical sciences, Village No.20,
Kalathumettupathai, Ganapathichettikulam, Kalapet, Puducherry
605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
755812068 |
| Fax |
|
| Email |
drmaha2508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidya MV |
| Designation |
MD Anaesthesia |
| Affiliation |
Pondicherry Institute of Medical sciences |
| Address |
Pondicherry Institute of Medical sciences, Village No.20,
Kalathumettupathai, Ganapathichettikulam, Kalapet, Puducherry
605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9585550838 |
| Fax |
|
| Email |
drmvvidya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahalakshmi M |
| Designation |
MD Anaesthesia |
| Affiliation |
Pondicherry Institute of Medical sciences |
| Address |
Pondicherry Institute of Medical sciences, Village No.20,
Kalathumettupathai, Ganapathichettikulam, Kalapet, Puducherry
605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7558120687 |
| Fax |
|
| Email |
drmaha2508@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology
,Pondicherry Institute of Medical Sciences,Village No.20,
Kalathumettupathai,
Ganapathichettikulam,
Kalapet, Puducherry
605014
|
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical Sciences . |
| Address |
Pondicherry Institute of Medical Sciences Village No.20,
Kalathumettupathai, Ganapathichettikulam Kalapet, Puducherry
605014
|
| 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 Mahalakshmi M |
Department of Anesthesiology,Pondicherry Institute of Medical Sciences |
Pondicherry Institute of Medical Sciences,Department of Anesthesiology,Village No.20,
Kalathumettupathai,
Ganapathichettikulam,
Kalapet, Puducherry
605014
Pondicherry
PONDICHERRY |
75581 20687
drmaha2508@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS institute Ethics committee |
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 |
Assessment of reversal time characteristics using full dose with two step administration
of Neostigmine for antagonizing Atracurium induced moderate block using
neuromuscular monitor –Double blinded randomized control trial
|
Group B : Patient will be receiving half dose of Neostigmine 30mcg/kg with
Glycopyrolate 6mcg/kg (10ml) reversal at TOFc of 3 and again remaining half dose
of Neostigmine 30mcg/kg with Glycopyrolate 6mcg/kg (10ml) will be receiving at
TOFr of 0.4
|
| Comparator Agent |
Assessment of reversal time characteristics using full dose with two step neostigmine adminstration for antagonising atracurium induced moderate block in general anaesthesia |
Group A : Patient will be receiving full dose of Neostigmine 60mcg/kg with
Glycopyrolate 12mcg/kg (10ml) reversal at TOFc of 3 and again 0.9% normal saline
(10ml) will be receiving at TOFr of 0.4
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient belonging to ASA 1 and 2
2.Patient posted for surgeries under general anaesthesia in PIMS
3.BMI -18 to 35 kg/m2.
Surgeries lasting for less than 2 hours |
|
| ExclusionCriteria |
| Details |
)Known allergy to anaesthetic drugs
2)Neuromuscular disease
3)Renal disorders ( serum creatinine > 1.8mg/dl)
4)Liver disorders ( liver function tests > 50% of normal value )
5) Surgical position that prevent access to neuromuscular monitoring |
|
|
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 |
To measure the effect of two step administration of neostigime after emergence of
TOFc of 3 in reducing the reversal time of atracurium induced moderate block in patient
undergoing general anaesthesia using inhalational anaesthesia as compared to full dose
administration.
|
Assessed intraoperatively and postoperatively 1hour(surgeries not more than approximately 2hours ). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To note the incidence of residual neuromuscular blockade postoperatively
2.To document the side effects of neostigmine |
Assessed intraoperatively & postoperatively 1hour(surgeries not more than approximately 2hours ).
Assessed intraoperatively , postoperative period at baseline, 5 minutes, 10 minutes,15 minutes,20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes, 45 minutes, 50 minutes,55 minutes,60 minutes |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
07/09/2025 |
| 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 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
|
Assessment of reversal time characteristics using full dose with two step administration of Neostigmine for antagonizing Atracurium induced moderate block using neuromuscular monitor –Double blinded randomized control trial |