| CTRI Number |
CTRI/2024/07/070154 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare sugammadex and neostigmine to acess hemodynamic response during the recovery of rocuronium in the brain surgery |
|
Scientific Title of Study
|
Comparative study between sugammadex and neostigmine to evaluate hemodynamic response during reversal of rocuronium in patient undergoing craniotomy surgery: a randomised double blind controlled 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 |
DR KIRTI VERMA |
| Designation |
junior resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna |
| Address |
Department of Anesthesiology Neuro OT Complex,1ST FLOOR, WARD BLOCK,Indira Gandhi Institute of Medical Sciences,Sheikhpura,Patna
BIHAR
800014
INDIA
Patna
BIHAR
800014
India |
| Phone |
7992256134 |
| Fax |
|
| Email |
kirti.kirtishalu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KIRTI VERMA |
| Designation |
junior resident |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology Neuro OT Complex,1ST FLOOR, WARD BLOCK,Indira Gandhi Institute of Medical Sciences,Sheikhpura,Patna
Patna
BIHAR
800014
India |
| Phone |
7992256134 |
| Fax |
|
| Email |
kirti.kirtishalu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ARVIND KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna |
| Address |
Department OF Anesthesiology,Neuro OT COMPLEX,1ST FLOOR WARD BLOCK,Indira Gandhi Institute of Medical Sciences,Sheikhpura,Patna
Patna
BIHAR
800014
India |
| Phone |
9534870908 |
| Fax |
|
| Email |
arvind007kumar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences,Patna |
|
Primary Sponsor
Modification(s)
|
| Name |
DR KIRTI VERMA |
| Address |
Department of Anesthesiology Neuro OT Complex,1ST FLOOR, WARD BLOCK,Indira Gandhi Institute of Medical Sciences,Seikhpura,Patna
800014
INDIA |
| Type of Sponsor |
Other [SELF] |
|
|
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 KIRTI VERMA |
Indira Gandhi Institute Of Medical Sciences Patna |
Department of Anesthesiology,Neuro OT Complex,First floor,WARD BLOCK,Indira Gandhi Institute of Medical Sciences,SHEIKHPURA,PATNA-800014
Patna
BIHAR |
7992256134
kirti.kirtishalu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Indira Gandhi Institute of Medical Sciences,Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neostigmine reversal agent |
patient received neostigmine 50 microgram/kg plus glycopyrrolate 10 microgram/kg |
| Intervention |
sugammadex reversal agent |
patient received sugammadex 2mg/kg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All pateints age group 18-65years with craniotomy surgeries and giving written informed consent.
ASA GRADE 1 TO 3. |
|
| ExclusionCriteria |
| Details |
1.Pateint refuse to participate.
2.Renal,Hepatic,Ventilatory Dysfunction.
3.Increased intracranial pressure.
4.Pregnancy or lactation.
5.Pateints with muscular dystrophies,myopathy,or cerebral palsy.
6.Pateints with a history of intolerance to any of the study drugs. |
|
|
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 compare the hemodynamic response Heart rate,SBP,DBP,MAP,SPO2 of sugammadex versus Neostigmine in reversal of rocuronium in pateints undergoing craniotomy surgery. |
2min,5min,10min,15min,30min,60min,2hr,6hr,12hr,18hr,24hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the side effects (PONV) of sugammadex versus neostigmine in reversal of rocuronium in pateints undergoing craniotomy surgery.
2.To evaluate the Train of four Response of sugammadex versus neostigmine in reversal of rocuronium in pateints undergoing craniotomy surgery. |
2min,5min,10min,15min,30min,60min,2hr,6hr,12hr,18hr,24hr.
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
14/07/2024 |
| 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="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
|
A total of 90 patients posted for elective craniotomy surgery and randomly divided into two equal groups (45each).we will compare the hemodynamic response of Sugammadex versus Neostigmine (Group S:sugammadex 2mg/kg versus Group N: neostigmine 50microgram/kg plus glycopyrrolate 10microgram/kg) in reversal of rocuronium.primary objective will be to compare the hemodynamic response(HR ,SBP,DBP,MAP,SPO2,) of sugammadex versus neostigmine in reversal of rocuronium in patients undergoing craniotomy surgery. secondary objective will be to evaluate side effects (PONV) and train of four response of sugammadex versus neostigmine in reversal of rocuronium in patients undergoing craniotomy surgery.we will record HR,SBP,DBP,MAP.SPO2,PONV,TOF at 2min,5min,10min,15min,30min,60min,2hr,6hr,12hr,18hr and 24hr. |