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

Ketamine Adverse Reaction Clinical Trial

Official title:

Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04490031
• Other study ID #: Hukm
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: March 2020
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: Muhammad Hafiz Ismail, MBBS
• Phone: 6016 3354384
• Email: muhdhafizismail88[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a double blinded study whereby both the surgeons and patients are blinded from the sedative agent used. Patients admitted to UKMMC requiring ERCP will randomized into 2 groups after evaluating the inclusion and exclusion criteria. Patients will be divided into two arms, Midazolam and Ketamine group respectively. Before the initiation of the the scope, patient would be given specified dose of sedation accordingly. All the parameters and outcome would be measured during and after the procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: April 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Malaysian citizens of who is able to give valid consent

• Patient planned for ERCP (either emergency or elective)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ketamine Adverse Reaction

Intervention

Drug:
• Ketamine Hydrochloride
patient in Ketamine group will be given Ketamine as sedative agent

Locations

Country	Name	City	State
Malaysia	University Kebangsaan Malaysia Medical center	Bandar Tun Razak	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	depth of sedation	based on Ramsay Sedation Scale, from a scale of 1-6.; Patient is anxious and agitated or restless, or both; Patient is co-operative, oriented, and tranquil; Patient responds to commands only; Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; Patient exhibits no response The aim of sedation is a score of 3-4	1 hour
Primary	completion rate	to evaluate completion rate between Ketamine and Midazolam group	1 hour
Secondary	Surgeon satisfaction score	subjective scoring of surgeon regarding overall experience of the ERCP from a score of 0-10.; 0- poor, 5- moderate, 10- excellent	within 4 hours after completion of ERCP
Secondary	Patient satisfaction score	subjective scoring of patients regarding overall experience of the ERCP from a score of 0-10.; 0- poor, 5- moderate, 10- excellent	within 4 hours after completion of ERCP
Secondary	evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms	recording the adverse events of each sedation.; Hypotension: defined as a systolic blood pressure drop greater than 20mmHg to a value less than 90mmHg; Hypertension: defined as a systolic blood pressure increase greater than 20mmHg or to a value more than 140mmHg; Bradycardia: defined as heart rate less than 50 after the initiation of sedation or decrease in heart rate more than 20 beats per minute; Tachycardia: defined as heart rate more than 100 after the initiation of sedation or increase in heart rate more than 20 beats per minute; Hypoxia: defined by oxygen saturation less than 95%; Respiratory rate abnormality; Nausea, vomiting, emergence symptoms	24 hours