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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversiti Kebangsaan Malaysia Medical Centre

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Malaysian citizens of who is able to give valid consent

Patient planned for ERCP (either emergency or elective)

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Ketamine Hydrochloride

    Drug

    patient in Ketamine group will be given Ketamine as sedative agent

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Midazolam groupNo intervention 0 interventions
Group B: Ketamine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 hour
2

completion rate

to evaluate completion rate between Ketamine and Midazolam group

Time frame
1 hour

Secondary outcomes

1

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

Time frame
within 4 hours after completion of ERCP
2

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

Time frame
within 4 hours after completion of ERCP
3

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

recording the adverse events of each sedation. 1. Hypotension: defined as a systolic blood pressure drop greater than 20mmHg to a value less than 90mmHg 2. Hypertension: defined as a systolic blood pressure increase greater than 20mmHg or to a value more than 140mmHg 3. Bradycardia: defined as heart rate less than 50 after the initiation of sedation or decrease in heart rate more than 20 beats per minute 4. Tachycardia: defined as heart rate more than 100 after the initiation of sedation or increase in heart rate more than 20 beats per minute 5. Hypoxia: defined by oxygen saturation less than 95% 6. Respiratory rate abnormality 7. Nausea, vomiting, emergence symptoms

Time frame
24 hours

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

University Kebangsaan Malaysia Medical centerRecruiting56000, Bandar Tun Razak, Kuala LumpurMalaysiaMalaysia

Sponsors and contacts

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