Sedation for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography

NCT04860167 | Completed DMC

• 1 other identifier: ILBSIndia3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study was performed to evaluate the role of BIS monitored sedation in reducing the dose of propofol and to know the effectiveness of pre-procedure administration of intravenous diclofenac sodium along with topical pharyngeal anesthesia in reducing the dose of propofol in patients undergoing endoscopic retrograde cholangiopancreatography.

Conditions

Biliary Colic

Keywords

Diclofenac; Propofol; Topical anaesthesia

Outcome Measures

Primary Outcomes (1)

• Total dose of propofol required in mg/kg/hr during ERCP procedure among different groups.

  Total dose of propofol required to complete the ERCP procedure was noted

  2 hours

Secondary Outcomes (3)

• Mean recovery time between different groups.

  24 hours

• Time taken to achieve eye opening to verbal stimulus among different groups

  24 hours

• Incidence of hypotension, bradycardia, limb movements and gag reflex during the ERCP procedure

  24 hours

Study Arms (3)

Group A

NO INTERVENTION

The intravenous infusion of propofol was administered for ERCP procedure based on clinical judgment and the patient's requirement.

Group B

ACTIVE COMPARATOR

The intravenous infusion of propofol was administered for ERCP procedure titrated to BIS value 60-80.

Drug: Propofol

Group C

ACTIVE COMPARATOR

Patients received 75 mg of inj. Diclofenac sodium (diluted in 100 ml of 0.9 % normal saline) intravenously 30 mins before the start of procedure \& topical pharyngeal anesthesia with 4 squirts of 10% lidocaine spray ( one squirt each to posterior pharyngeal wall, base of tongue, and bilateral palatoglossal and palatopharyngeal folds ) 5 mins before the start of ERCP procedure. Intravenous infusion of propofol was administered for ERCP procedure titrated to BIS value 60-80.

Drug: Diclofenac Sodium and Lignocaine 10 % spray

Interventions

Propofol DRUG

Injection propofol was given to keep the BIS value 60-80 during the ERCP procedure

Also known as: Neorof

Group B

Diclofenac Sodium and Lignocaine 10 % spray DRUG

Injection Diclofenac sodium was given in the preoperative area 30 minutes before the procedure and four squirts of 10% lignocaine were given 5 minutes prior to the start of the procedure

Also known as: Dynapar

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-65 yrs
• ASA I \& II

You may not qualify if:

• Age \< 18 yrs \& \> 65 yrs
• ASA III \& IV patients
• Chronic Liver Disease
• Pregnant patients
• Patients with a history of (H/O) Drug abuse
• Patients refusing consent
• H/o Acute kidney injury
• H/o allergy to propofol / lidocaine/ NSAIDS
• Post liver transplant patients
• Patients with h/o egg allergy

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Gaurav Sindwani

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Related Publications (5)

• Patai A, Solymosi N, Mohacsi L, Patai AV. Indomethacin and diclofenac in the prevention of post-ERCP pancreatitis: a systematic review and meta-analysis of prospective controlled trials. Gastrointest Endosc. 2017 Jun;85(6):1144-1156.e1. doi: 10.1016/j.gie.2017.01.033. Epub 2017 Feb 4.

  PMID: 28167118 RESULT

• Quesada N, Judez D, Martinez Ubieto J, Pascual A, Chacon E, De Pablo F, Minchole E, Bello S. Bispectral Index Monitoring Reduces the Dosage of Propofol and Adverse Events in Sedation for Endobronchial Ultrasound. Respiration. 2016;92(3):166-75. doi: 10.1159/000448433. Epub 2016 Sep 7.

  PMID: 27598398 RESULT

• Wehrmann T, Grotkamp J, Stergiou N, Riphaus A, Kluge A, Lembcke B, Schultz A. Electroencephalogram monitoring facilitates sedation with propofol for routine ERCP: a randomized, controlled trial. Gastrointest Endosc. 2002 Dec;56(6):817-24. doi: 10.1067/mge.2002.129603.

  PMID: 12447291 RESULT

• White PF, Sacan O, Tufanogullari B, Eng M, Nuangchamnong N, Ogunnaike B. Effect of short-term postoperative celecoxib administration on patient outcome after outpatient laparoscopic surgery. Can J Anaesth. 2007 May;54(5):342-8. doi: 10.1007/BF03022655.

  PMID: 17470884 RESULT

• Paspatis GA, Chainaki I, Manolaraki MM, Vardas E, Theodoropoulou A, Tribonias G, Konstantinidis K, Karmiris K, Chlouverakis G. Efficacy of bispectral index monitoring as an adjunct to propofol deep sedation for ERCP: a randomized controlled trial. Endoscopy. 2009 Dec;41(12):1046-51. doi: 10.1055/s-0029-1215342. Epub 2009 Dec 4.

  PMID: 19967620 RESULT

MeSH Terms

Interventions

Propofol; Diclofenac; Lidocaine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• gaurav sindwani, md

  ilbs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Department of Anaesthesiology, Principal Investigator

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 26, 2021
• Study Start: September 10, 2018
• Primary Completion: September 26, 2019
• Study Completion: November 14, 2019
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)