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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04490031
Other study ID # Hukm
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT03525912 - Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions N/A
Completed NCT03979105 - Cardiovascular Safety After Continuous Ketamine Infusion