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A pilot study comparing two airway protection devices to provide general anesthesia during hepatobiliary surgery.

LMA Proseal a safe alternative to Endotracheal intubation for prolonged hepatobiliary surgery: a pilot study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066897
Enrollment
30
Registered
2024-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: LMA Proseal: Patients will be allotted after written informed consent is given by them and they will be allotted in two groups: group A & group B according to sequential randomization m

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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. Ventilatory efficacy will be evaluated by means of peak pressure, driving pressure, leak (discrepancy between inspiratory and expiratory tidal volume). Pulmonary gas exchange will be evaluated as PaO2, PaCO2, ETCO2. Timepoint: base line, hourly parameter at 1st,2nd,3rd,4th,5th,6th, 7th,8th hour

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Aniruddha Banerjee

Institute of Liver & Biliary Sciences

banerjeeaniruddha194@gmail.com8583807964

Outcome results

None listed

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