Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)

NCT04490031 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Hukm
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of Ketamine will be compared to the standard sedation in our center, which is Midazolam in combination with Pethidine as analgesia.

Conditions

Ketamine Adverse Reaction

Outcome Measures

Primary Outcomes (2)

• depth of sedation

  based on Ramsay Sedation Scale, from a scale of 1-6. 1. Patient is anxious and agitated or restless, or both 2. Patient is co-operative, oriented, and tranquil 3. Patient responds to commands only 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6. Patient exhibits no response The aim of sedation is a score of 3-4

  1 hour

• completion rate

  to evaluate completion rate between Ketamine and Midazolam group

  1 hour

Secondary Outcomes (3)

• Surgeon satisfaction score

  within 4 hours after completion of ERCP

• Patient satisfaction score

  within 4 hours after completion of ERCP

• evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms

  24 hours

Study Arms (2)

Midazolam group

NO INTERVENTION

Standard sedation for ERCP in UKMMC

Ketamine group

EXPERIMENTAL

Drug: Ketamine Hydrochloride

Interventions

Ketamine Hydrochloride DRUG

patient in Ketamine group will be given Ketamine as sedative agent

Ketamine group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Malaysian citizens of who is able to give valid consent
• Patient planned for ERCP (either emergency or elective)

You may not qualify if:

• Known hypersensitivity towards Ketamine or Midazolam
• Patient refusal to participate or unable to give consent
• Increased intracranial pressure, acute stroke (\<3 months), intracranial haemorrhage (\<3 months)
• Uncontrolled hypertension (BP\>160/100) and tachycardia (Heart rate \>120)
• Acute myocardial infarction, acute coronary syndrome (\<3 months)
• Tachyarrythmia
• Pregnancy
• IVDU or substance abuse patient
• Patient with history of hallucination
• Child's Pugh Class C

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

University Kebangsaan Malaysia Medical center

Bandar Tun Razak, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ian Chik, MD

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

• Norma mohamad, MD

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

• Zamri Zuhdi, MD

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

• Azlanudin Azman, MD

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

• Muhammad Hafiz Ismail, MD

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Hafiz Ismail, MBBS

CONTACT

6016 3354384; muhdhafizismail88@gmail.com

Ian Chik, MD

CONTACT

6012 3243404; ianchikmd@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both the patients and surgeon will be blinded from knowing the sedative agent
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: July 28, 2020
• Study Start: March 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: April 30, 2021
• Last Updated: July 28, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)