Comparison of use of agents used to make unconscious by two different routes using a device placed in mouth called as Laryngeal Mask Airway (LMA) Gastro for a procedure done via an instrument inserted through mouth

Comparison of use of inhalational agent versus total intravenous anaesthesia (TIVA) with Laryngeal mask airway (LMA) Gastro for Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures under general anaesthesia - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/057020

Enrollment

Registered

2023-08-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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: Inhalational Agent: Sevoflurane at 2% dial flow concentration with oxygen flow of 4L/min to achieve a MACsevo of 1.2 unit after LMA Gastro insertion. Haemodynamic parameters monitored d

Eligibility

Inclusion criteria

Inclusion criteria: ASA I- III Patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures for biliary or pancreatic interventions Weight > 30 kg Anticipated procedure time > 30 min Fasting at least 6 hrs for solids and 2 hrs for clear liquids

Exclusion criteria

Exclusion criteria: Refusal of consent Restricted mouth opening (inter-incisor distance 35 kg/m2 Altered consciousness (GCS

Design outcomes

Primary

Measure	Time frame
To compare the recovery time while using inhalational agent versus TIVA with LMA GastroTM for ERCP procedures under general anaesthesiaTimepoint: Pre procedure 02 minutes after induction 00h 10m 00h 20m 00h 30m 00h 45m 00h 60m 01h 30m 02h 00m 02h 30 m	—

Secondary

Measure	Time frame
Number of attempts for successful insertion of LMA Gastro Any need for rescue methods of anaesthesia or use of anaesthetic agents for maintenance Ease of performing procedure by GI physicians. To monitor haemodynamic parameters between the two groups (heart rate, blood pressure, oxygen saturation & end tidal carbon dioxide). Any complications due to usage of LMA like trauma (visualisation of blood on LMA Gastro after removal), sore throat post procedure and post procedure laryngospasmTimepoint: Pre procedure 02 minutes after induction 00h 10m 00h 20m 00h 30m 00h 45m 00h 60m 01h 30m 02h 00m 02h 30 m	—

Measure

Time frame

Number of attempts for successful insertion of LMA Gastro Any need for rescue methods of anaesthesia or use of anaesthetic agents for maintenance Ease of performing procedure by GI physicians. To monitor haemodynamic parameters between the two groups (heart rate, blood pressure, oxygen saturation & end tidal carbon dioxide). Any complications due to usage of LMA like trauma (visualisation of blood on LMA Gastro after removal), sore throat post procedure and post procedure laryngospasmTimepoint: Pre procedure 02 minutes after induction 00h 10m 00h 20m 00h 30m 00h 45m 00h 60m 01h 30m 02h 00m 02h 30 m

—

Countries

India

Contacts

Public ContactDr Amala Gurunath Kudalkar

Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital

vidyatharu93@gmail.com9945967946

Outcome results

None listed

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