CTRI

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CTRI Number

CTRI/2023/09/057759 [Registered on: 18/09/2023] Trial Registered Prospectively

Last Modified On:

15/09/2023

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

PROSPECTIVE

Study Design

Single Arm Study

Public Title of Study

A study to assess inadequate neuromuscular recovery in postoperative period immediately on arrival and after 30 minutes of arrival by measuring Train of Four ratios after use of intermediate muscle relaxant intraoperatively

Scientific Title of Study

A study to assess residual post operative neuromuscular blockade following use of intermediate muscle relaxant in early and late recovery period

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Amrita Kaur Sandhu
Designation	Secondary DNB resident Anaesthesia
Affiliation	Max Superspeciality Hospital , Phase 6 ,Mohali
Address	Department of anaesthesia ,OT complex first floor , Max Superspeciality Hospital , Phase 6 , Mohali Chandigarh CHANDIGARH 160056 India
Phone	8264144773
Fax
Email	sandhuamrita72@gmail.com

Details of Contact Person
Scientific Query

Name	DR Y K Batra
Designation	Head of department , Department of Anaesthesia
Affiliation	Max Superspeciality Hospital , Phase 6 , Mohali
Address	Department of Anaesthesia, OT complex first floor , Max Superspeciality Hospital ,Phase 6 , Mohali Chandigarh CHANDIGARH 160056 India
Phone	9646624870
Fax
Email	ykbatrapgi@gmail.com

Details of Contact Person
Public Query

Name	DR Y K Batra
Designation	Head of Department, Department of Anaesthesia
Affiliation	Max Superspeciality Hospital , Phase 6 , Mohali
Address	Department of Anaesthesia, OT complex first floor , Max Superspeciality Hospital , Phase 6 , Mohali Chandigarh CHANDIGARH 160056 India
Phone	9646624870
Fax
Email	ykbatrapgi@gmail.com

Source of Monetary or Material Support

Max Superspeciality Hospital ,Phase 6 , Mohali

Primary Sponsor

Name	Max Superspeciality Hospital
Address	Max Superspeciality Hospital , Phase 6 ,Mohali
Type of Sponsor	Private hospital/clinic

Details of Secondary Sponsor

Name	Address
Nil	Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Amrita Kaur Sandhu	Max Superspeciality Hospital	Department of Anaesthesia, OT Complex first floor , Max Superspeciality Hospital , Phase 6 , Mohali Chandigarh CHANDIGARH	8264144773 sandhuamrita72@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee , Max Superspeciality Hospital , Mohali	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil
Comparator Agent	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1.ASA physical status I or II 2.Patients who have given consent for study 3.Admission for elective surgery 4.Administration of general anaesthesia for surgery 5.Administration of intermediate muscle relaxant for surgery

ExclusionCriteria

Details

1.ASA physical status III or more than III
2.Evidence of renal , hepatic , metabolic or neuromuscular diseases
3.Admission for emergency surgery
4.Ejection fraction<50%
5.Patients who refused to give consent for study

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome

TimePoints

To evaluate post operative residual neuromuscular blockade by determining TOF ratios in early & late recovery period following use of intermediate muscle relaxant. It will help to determine the effects of duration of surgery & anaesthesia , total intraoperative dosage of intermediate muscle relaxant and time interval between last dose of muscle relaxant and extubation on post operative residual neuromuscular blockade by determining TOF ratios in PACU.

1 year

Secondary Outcome

Outcome	TimePoints
To determine effects of duration of surgery & anaesthesia & total intraoperative dosage of intermediate muscle relaxant and time interval between last dose of muscle relaxant and extubation on post operative residual neuromuscular blockade in post anaesthesia care unit	1 year

Target Sample Size

Total Sample Size="102"
Sample Size from India="102"
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)

25/09/2023

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

25/09/2023

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 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

THIS STUDY IS PROSPECTIVE , OBSERVATIONAL STUDY THAT WILL BE ORGANISED AND CARRIED OUT IN THE DEPARTMENT OF ANAESTHESIOLOGY , MAX SUPER SPECIALITY HOSPITAL ,MOHALI , PUNJAB WITH DUE AUTHORISATION FROM THE INSTITUITIONAL ETHICS COMITTEE AND REVIEW BOARD AND IN COMPLIANCE TO INFORMED , WRITTEN CONSENTS TAKEN FROM THE PATIENTS. THIS STUDY WILL ASSESS POSTOPERATIVE RESIDUAL NEUROMUSCULAR BLOCKADE BY DETERMINING TOF RATIOS IN EARLY AND LATE RECOVERY PERIOD FOLLOWING USE OF INTERMEDIATE MUSCLE RELAXANT. THIS STUDY WILL HELP IN DETERMINING THE EFFECTS OF DURATION OF SURGERY AND ANAESTHESIA,TOTAL INTRAOPERATIVE DOSAGE OF INTERMEDIATE MUSCLE RELAXANT AND TIME INTERVAL BETWEEN LAST DOSE OF MUSCLE RELAXANT AND EXTUBATION ON POSTOPERATIVE RESIDUAL NEUROMUSCULAR BLOCKADE BY DETERMINING TOF RATIOS IN RECOVERY ROOM .