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To use the device for ERCP(Endoscopic Retrograde Cholangiopancreatography) procedure by using 2 different techniques for giving general anaesthesia

Comparison of TCI(Targeted Control Infusion) versus TIVA(Total Intravenous Anaesthesia) using LMA Gastro for ERCP(Endoscopic Retrograde Cholangiopancreatography) procedure under General Anaesthesia : A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029189
Enrollment
54
Registered
2020-11-17
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: K00-K95- Diseases of the digestive system Health Condition 2: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere

Interventions

Intervention1: LMA Gastro Airway: Induction of Anesthesia in both the groups will be followed by the insertion of the LMA® GastroTM Airway using the loss of verbal communication, attainment of BIS (4

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status classification 1, 2 & 3 18 years and older, fasting for at least 6 h for solids and 2 h for clear liquids.

Exclusion criteria

Exclusion criteria: Patients at increased risk of pulmonary aspiration will be excluded. Allergy to propofol or lipid emulsion or egg lecithin. Patients posted for emergency ERCP Patient with anticipated difficult mask ventilation, difficult intubation or difficult LMA insertion.

Design outcomes

Primary

MeasureTime frame
To compare the recovery time after cessation of propofol infusion in both the groups Timepoint: At induction as baseline At 10 min after induction At every 10 min after induction intraoperatively during procedure At the end of procedure after removal of LMA Gastro. At post operatively till 24 hrs

Secondary

MeasureTime frame
Airway related events after insertion of LMA Gastro for 24 hours post-insertion. The following conditions will be categorized as airway related events: Visualization of blood on the LMA, postoperative laryngospasm defined as stridor, airway obstruction requiring insertion of an airway device, sore throat and hoarseness of voice.Timepoint: At induction as baseline At 10 min after induction At every 10 min after induction intraoperatively during procedure At the end of procedure after removal of LMA Gastro. At post operatively till 24 hrs;Comparison of the BIS score between the two groups during the entire procedure. Timepoint: At induction as baseline At 10 min after induction At every 10 min after induction intraoperatively during procedure At the end of procedure after removal of LMA Gastro. ;Ease of LMA®GastroTM Airway insertion condition will be graded as â??easyâ?? or â??difficultâ?? by the attending anesthesiologist, according to the number of airway manipulations required. If more than one airway manipulations are required, the insertion will be graded as â??difficultâ??. The first attempt success rate will also be noted. Timepoint: At induction as baseline At 10 min after induction ;Endoscope insertion will be graded as â??easyâ?? or â??difficultâ?? by the attending endoscopist. It will be graded â??difficultâ?? if more than one manipulation is required. The number of attempts of insertion of endoscope device through the endoscopic channel of LMA GASTRO will be noted. Timepoint: At induction as baseline At 10 min after induction ;The total dose of propofol used between the groups.Timepoint: At induction as baseline At 10 min after induction At every 10 min after induction intraoperatively during procedure At the end of procedure after removal of LMA Gastro. ;To study the time taken for achieving the PACU discharge criteria.Timepoint: At induction as baseline At 10 min after induction At every 10 min after induction intraoperatively duri

Countries

India

Contacts

Public ContactDr Debendra Kumar Tripathy

All India Institute of Medical Science

drdebendra@gmail.com9443278806

Outcome results

None listed

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