A study comparing addition of lignocaine or ketamine to propofol for producing sleep during endoscopic procedures.

Lignocaine versus ketamine as an adjunct to propofol for optimal sedation during endoscopic retrograde cholangiopancreatography (ERCP): a randomized controlled trial - LIKE-ERCP

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063736

Enrollment

140

Registered

2024-03-06

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: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Lignocaine infusion: Before starting the endoscopy procedure patients will receive a loading dose of lignocaine (1:20 mg dilution) 1.0mg per kg IV and a bolus dose of propofol 1.0mg pe

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists physical status 1 and 2

Exclusion criteria

Exclusion criteria: Refusal of consent Patient having undergone prior ERCP Pre-existing heart disease, renal failure, decompensated cirrhosis or liver failure Pregnancy. BMI greater than 35 kg per m2 Known allergy to study drugs

Design outcomes

Primary

Measure	Time frame
The difference in the mean propofol consumption (mg per kg per hour) between the two groups. Timepoint: At the end of procedure	—

Secondary

Measure	Time frame
Average heart rate and average mean arterial pressure.Timepoint: During the procedure;Endoscopist satisfaction on Likert scale (0-3)Timepoint: At the end of procedure;Incidence of ‘patient discomfort’ defined as =1 of the following – bucking, retching, coughing or gaggingTimepoint: During the procedure;Incidence of emergence agitation on Richmond Agitation Sedation Scale (RASS)Timepoint: At the end of procedure;Need for the use of airway adjunctsTimepoint: During the procedure;Number of significant episodes of desaturation (SpO2 less than 95%) Timepoint: During the procedure ;Number of times rescue boluses of propofol is needed.Timepoint: During the procedure;Patient Pain scores on Numerical rating Scale (NRS 0-10)Timepoint: At 30 minutes post procedure;Patient satisfaction on Likert scale (0-3)Timepoint: At 30 minutes post procedure;Time taken to achieve (=9) on Modified Aldrete ScoreTimepoint: In the post procedure period;Time taken to achieve score of 3 on Ramsay sedation scale (RSS) after stopping infusionsTimepoint: At the end of procedure	—

Measure

Time frame

Average heart rate and average mean arterial pressure.Timepoint: During the procedure;Endoscopist satisfaction on Likert scale (0-3)Timepoint: At the end of procedure;Incidence of ‘patient discomfort’ defined as =1 of the following – bucking, retching, coughing or gaggingTimepoint: During the procedure;Incidence of emergence agitation on Richmond Agitation Sedation Scale (RASS)Timepoint: At the end of procedure;Need for the use of airway adjunctsTimepoint: During the procedure;Number of significant episodes of desaturation (SpO2 less than 95%) Timepoint: During the procedure ;Number of times rescue boluses of propofol is needed.Timepoint: During the procedure;Patient Pain scores on Numerical rating Scale (NRS 0-10)Timepoint: At 30 minutes post procedure;Patient satisfaction on Likert scale (0-3)Timepoint: At 30 minutes post procedure;Time taken to achieve (=9) on Modified Aldrete ScoreTimepoint: In the post procedure period;Time taken to achieve score of 3 on Ramsay sedation scale (RSS) after stopping infusionsTimepoint: At the end of procedure

—

Countries

India

Contacts

Public ContactSoumya Sundaresh

All India Institute of Medical Sciences, New Delhi

Priyankar.k.datta@gmail.com9830771756

Outcome results

None listed

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