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Comparison of two methods of securing the airway under general anesthesia for endoscopy procedures

Not Applicable
Conditions
Health Condition 1: K80-K87- Disorders of gallbladder, biliary tract and pancreas
Registration Number
CTRI/2020/08/027268
Lead Sponsor
Research Section AIIMS
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Age 18-65 years

2.ASA status 1 â?? 3

3.Patients undergoing therapeutic ERCP for biliary or pancreatic interventions.

4.Height > 155 cm

5.Weight >30 kg

6.Anticipated procedure time >30min

Exclusion Criteria

1.Refusal of consent.

2.Reduced mouth opening (inter-incisor distance < 3 cm).

3.Anticipated difficult intubation

4.Propofol allergy

5.Severe left ventricular dysfunction.

6.Severe chronic obstructive pulmonary disease.

7.Altered consciousness (GCS < 8)

8.Fasting period of <8 hours for solids, <6 hours for milk and <2 hours for water.

9.Active gastroesophageal reflux disease.

10.BMI >35kg/m2

11.Clinically detectable ascites

12.Pregnancy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To determine the time to emergence with LMA Gastro and endotracheal tube based general anesthesia during ERCP procedures. (primary objective) Co-primary outcome would be incidence of significant respiratory adverse events. <br/ ><br>The recovery time will be noted from the time of extubation to shifting of the patient from endoscopy theatre to recovery room.Timepoint: Primary outcome: The time to emergence with LMA Gastro and endotracheal tube based general anesthesia during ERCP procedures will be done after the procedure once. <br/ ><br>Co-primary outcome: would be incidence of significant respiratory adverse events recorded during the procedure as and when they happen. <br/ ><br>The recovery time will recorded once after the procedure in the recovery room after procedure.
Secondary Outcome Measures
NameTimeMethod
1.Gastroenterologist satisfaction <br/ ><br>2.Number of attempts and first attempt success rate at endoscope insertion. <br/ ><br>3.Anesthetist satisfaction <br/ ><br>4.Number of attempts and time taken at airway device insertion. <br/ ><br>5.Incidence of device insertion failure. <br/ ><br>6.Conversion of one airway device to other during the procedure <br/ ><br>7.Recovery time <br/ ><br>8.Incidence of hypotension, bradycardia, pharyngeal bleed, gastroesophageal reflux and pulmonary aspiration, and post-procedure sore throat. <br/ ><br>Timepoint: 2-6 will be recorded during the insertion of the airway device and endoscope <br/ ><br>1,7&8 will be recorded after the end of procedure
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