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A clinical trial to study the effects of two devices I Gel and LMA Proseal in patients undergoing Laparoscopic Gall Bladder Removal Surgery

Efficacy of Proseal Lma vs I-gel in the different head and neck positions

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031589
Enrollment
100
Registered
2021-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K800- Calculus of gallbladder with acutecholecystitis Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: SUPRAGLOTTIC AIRWAY DEVICE PROSEAL LMA: After Anaesthetic Induction and successful insertion of supraglottic airway device , device will be connected to Anaesthesia Workstation ., the p

Sponsors

Shri guru ram rai institute of medical health and sciences Post graduate
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Age 18-65years 2)American Society of Anaesthesiologist Grade 1&2 3)Adult male and female 4)Weight 30 to 70kg

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1)Patientâ??s refusal 2)Weight 3)Body Mass Index > 30kg/m2 4)Cervical spine pathology 5)Operation duration > 3hrs 6)High risk aspiration (non fasted, gastro-esophageal reflux) 7)Pre-operative sore-throat 8)Poor dentition with high risk of damage 9)Pregnancy 10) Anticipated Difficult Airway 11) Pneumothorax 12) Room air sat less than 95% on Room Air 13) Vocal Cord Palsy 14) Craniofacial Anomaly 15) Congenital Upper Airway Anomaly 16 ) Upper Airway Disease 17) Head and Neck Tumor Status Post Radiotherapy

Design outcomes

Primary

MeasureTime frame
To evaluate and compare efficacy of LMA Proseal and I-gel in different head and neck positions in patients undergoing Laparoscopic Cholecystectomy. The primary outcome was the Oro Pharyngeal Leak Pressure of the two study devices in maximum flexion, extension and neutral positionTimepoint: Intraoperative and 24 hour post surgery

Secondary

MeasureTime frame
Secondary outcomes included are : a) Peak inspiratory pressure (PIP) b) Expired tidal volume, c) Ventilation Scoring d)Intra-operative and post-operative complications of LMA Proseal and I-Gel. Timepoint: Intraoperative and 24 hour post surgery

Countries

India

Contacts

Public ContactDr Jitesh Talwar

Shri Guru Ram Rai University

dranoopnegi@gmail.com9149045123

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026