A trial comparing addition of lignocaine or ketamine to propofol for sedation during endoscopic procedures.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068624

Enrollment

150

Registered

2024-06-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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) 1.0 mg/kg IV and a bolus dose of propofol 1.0 mg/kg IV

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Refusal of consent Pre-existing heart disease Renal or liver insufficiency Pregnancy. BMI > 35 kg/m2 Known allergy to study drugs

Design outcomes

Primary

Measure	Time frame
The difference in the mean propofol consumption (mg/kg/h) 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 gagging Timepoint: During the procedure;Incidence of emergence agitation on Richmond Agitation Sedation Scale (RASS)Timepoint: At the end of procedure;Number of significant episodes of desaturation (SpO2 <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 minute 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 gagging Timepoint: During the procedure;Incidence of emergence agitation on Richmond Agitation Sedation Scale (RASS)Timepoint: At the end of procedure;Number of significant episodes of desaturation (SpO2 <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 minute 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