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

Efficacy of Specialized Laryngeal Mask Airway Versus Endotracheal Tube for Therapeutic Endoscopic Procedures Under General Anesthesia a Randomized Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027268
Enrollment
60
Registered
2020-08-20
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: K80-K87- Disorders of gallbladder, biliary tract and pancreas

Interventions

Intervention1: LMAï?? GastroTM Cuff PilotTM Airway: The patients undergoing the ERCP procedures will be anesthetized with standard technique without muscle relaxation and LMA gastro airway will be in

Sponsors

Research Section AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1.Refusal of consent. 2.Reduced mouth opening (inter-incisor distance 3.Anticipated difficult intubation 4.Propofol allergy 5.Severe left ventricular dysfunction. 6.Severe chronic obstructive pulmonary disease. 7.Altered consciousness (GCS 8. Fasting period of 9.Active gastroesophageal reflux disease. 10.BMI >35kg/m2 11.Clinically detectable ascites 12.Pregnancy

Design outcomes

Primary

MeasureTime frame
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. 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. Co-primary outcome: would be incidence of significant respiratory adverse events recorded during the procedure as and when they happen. The recovery time will recorded once after the procedure in the recovery room after procedure.

Secondary

MeasureTime frame
1. Gastroenterologist satisfaction 2. Number of attempts and first attempt success rate at endoscope insertion. 3. Anesthetist satisfaction 4. Number of attempts and time taken at airway device insertion. 5. Incidence of device insertion failure. 6. Conversion of one airway device to other during the procedure 7. Recovery time 8. Incidence of hypotension, bradycardia, pharyngeal bleed, gastroesophageal reflux and pulmonary aspiration, and post-procedure sore throat. Timepoint: 2-6 will be recorded during the insertion of the airway device and endoscope 1,7&8 will be recorded after the end of procedure

Countries

India

Contacts

Public ContactAnju Gupta

AIIMS

dranjugupta2009@rediffmail.com9911573371

Outcome results

None listed

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