A pilot study comparing two airway protection devices to provide general anesthesia during hepatobiliary surgery.
Phase 4
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/05/066897
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adult patients of ASA grade I, II, III undergoing hepatobiliary surgery in Institute of liver and biliary science where expected duration of surgery is = 6 hours and gut handling during surgery is minimal
Exclusion Criteria
Patients with anticipated difficult airway
Inadequate NPO status
Obese, BMI more than 35
ASA grade IV, V with serious comorbidities.
Emergency surgeries
Patient who has not given consent to participate in study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective is to assess feasibility of LMA Proseal by means of ventilatory efficacy and pulmonary gas exchange in prolonged hepatobiliary surgery and to compare its efficacy with endotracheal tube. <br/ ><br>Ventilatory efficacy will be evaluated by means of peak pressure, driving pressure, leak (discrepancy between inspiratory and expiratory tidal volume). <br/ ><br>Pulmonary gas exchange will be evaluated as PaO2, PaCO2, ETCO2. <br/ ><br>Timepoint: base line, hourly parameter at 1st,2nd,3rd,4th,5th,6th, 7th,8th hour
- Secondary Outcome Measures
Name Time Method Hemodynamic variation during insertion and emergenceTimepoint: baseline, 0,1,3,5,10 minutes after insertion of LMA or ET tube, after discontinuation of anesthesia,time of extubation, 5 minutes post extubation;incidence of post operative nausea vomiting, postoperative pulmonary complications, hoarseness of voice, sore throatTimepoint: up to 3 days post surgery