Comparison of two methods of securing the airway under general anesthesia for endoscopy procedures
- 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
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
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
Name Time Method 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
Name Time Method 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