CTRI

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CTRI Number

CTRI/2015/06/005919 [Registered on: 16/06/2015] Trial Registered Retrospectively

Last Modified On:

15/06/2015

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Medical Device

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparison of different methods of airway management in patients undergoing laparoscopic surgeries.

Scientific Title of Study

Comparison of Supreme and Proseal Laryngeal Mask Airway in patients undergoing laparoscopic cholecystectomy

Trial Acronym

RACE

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Nitika Goel
Designation	Postgraduate Junior Resident
Affiliation	Government Medical College Hospital Chandigarh
Address	Department of Anaesthesia and Intensive care, Government Medical College Hospital, Sector 32, Chandigarh Department of Anaesthesia and Intensive care, Government Medical College Hospital, Sector 32, Chandigarh Chandigarh CHANDIGARH 160032 India
Phone	8826622159
Fax
Email	nitikagoel7@gmail.com

Details of Contact Person
Scientific Query

Name	L K Anand
Designation	Associate Professor
Affiliation	Government Medical College Hospital Chandigarh
Address	Department of Anaesthesia and Intensive care, Government Medical College Hospital, Sector 32, Chandigarh Department of Anaesthesia and Intensive care, Government Medical College Hospital, Sector 32, Chandigarh Chandigarh CHANDIGARH 160032 India
Phone	9646121522
Fax
Email	lkanand11@yahoo.com

Details of Contact Person
Public Query

Name	L K Anand
Designation	Associate Professor
Affiliation	Government Medical College Hospital Chandigarh
Address	Department of Anaesthesia and Intensive care, Government Medical College Hospital, Sector 32, Chandigarh Department of Anaesthesia and Intensive care, Government Medical College Hospital, Sector 32, Chandigarh Chandigarh CHANDIGARH 160032 India
Phone	9646121522
Fax
Email	lkanand11@yahoo.com

Source of Monetary or Material Support

Department of Anaesthesia and Intensive care, Government Medical College Hospital, Sector 32, Chandigarh

Primary Sponsor

Name	Govt Medical College and Hospital
Address	Govt. Medical College and Hospital Sector 32 Chandigarh
Type of Sponsor	Government medical college

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 Lakesh Anand	Department of Anaesthesia and Intensive Care	Govt. Medical College and Hospital, Sector 32, Chandigarh Chandigarh CHANDIGARH	09646121522 lkanand11@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Patients with Gall Bladder Stone disease for elective cholecystectomy were chosen. Pateints with mouth opening less than 2.5 cm,with upper respiratory tract infection were excluded. ,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Proseal LMA	Modified version of classic LMA, offering a more effective seal around the glottis with a drain tube as a bypass channel for gastric access, designed to improve controlled ventilation, airway protection and diagnosis of misplacement.
Intervention	Supreme LMA	New supraglottic airway device that presents combined features pf Proseal LMA, Fastrach LMA and Unique LMA. Clinical and fibreoptic evaluation of SLMA showed easy insertion, optimal laryngeal fit and low airway morbidity.

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Age group b/w 20 to 60 years 2. American Society of Anaesthesiologist (ASA) physical status I and II 3. Patients scheduled for elective laparoscopic cholecystectomy under general anaesthesia.

ExclusionCriteria

Details

The following patients were excluded from the study.
1. Patients with known or predicted difficult airway or MPG III/IV.
2. Patients with mouth opening of less than 2.5 cm. .
3. Patients with history of upper respiratory tract infection.
4. Patients with increased risk of regurgitation and aspiration.
5. Patients with a body mass index (BMI) > 35 kg.m.-2
6. Patients unable to understand the study protocol.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Other

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Ease of insertion of equipment, Cuff Pressure of equipment, oropharyngeal leak pressure	Time for successful insertion of equipment and time of insertion of orogastric tube

Secondary Outcome

Outcome	TimePoints
Any morbidity,adverse effect	In first 24 hours

Target Sample Size

Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial

N/A

Date of First Enrollment (India)

05/05/2010

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

presently no publication of the study has been made.

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

The primary purpose of the study is to compare the efficacy between Supreme laryngeal mask airway and Proseal laryngeal mask airway in laparoscopic surgeries and to study any difference between hemodynamic and ventilatory parameters between the two groups. Supreme laryngeal mask airway was found to be more efficacious in terms of ease and time of insertion of laryngeal mask airway. However no difference was found in the hemodynamic and ventilatory parameters between the two groups.