Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography.

Sponsor

National University of Malaysia (Other)

Overall Status

Recruiting

CT.gov ID

NCT06111872

Collaborator

(none)

Enrollment

Location

Arms

11.4

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Does Ketamine-Midazolam have a better efficacy and safety profile compared to Midazolam - Pethidine in Endoscopic Retrograde Cholangiopancreatography (ERCP)?

Condition or Disease	Intervention/Treatment	Phase
Cholangitis Pancreatic Cancer Choledocholithiasis Choledochal Cyst	Drug: Ketamine Drug: Midazolam Drug: Pethidin	Phase 2

Detailed Description

Ketamine- Midazolom is more efficacious in producing desired sedative state and have a better safety profile as a sedative agent in ERCP compared to Midazolam- Pethidine. The usage of sedative agent in ERCP depends on surgeon's preferences and availability of the drugs. The most commonly used sedatives in ERCP is Midazolam with pethidine. The use of Midazolam , however, is related to:

20-45% failure of sedation during ERCP
Cardio-respiratory depression - apnoea: 15.4%, hypotension: 15.7%, bradycardia: 6.8%

Due to the proven efficacy and safety profile of ketamine-midazolam as a sedative agent in procedural sedation, the investigators propose that the use of ketamine-midazolam as a sedative agent in ERCP is more effective and better safety profile when compared to Midazolam- Pethidine. The synergistic effect means to reduce the total dose of midazolam used.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomized into the intervention or control group (Intervention group will receive Ketamine - Midazolam and control group will receive Midazolam- Pethidine as a sedative agent in ERCPPatients will be randomized into the intervention or control group (Intervention group will receive Ketamine - Midazolam and control group will receive Midazolam- Pethidine as a sedative agent in ERCP

Masking:

Single (Care Provider)

Masking Description:

Care provider is blinded from knowing the group of the study. However patients are informed regarding the drugs received

Primary Purpose:

Treatment

Official Title:

Combination Use of Intravenous Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography ; A Randomized Control Trial

Actual Study Start Date :

Jul 18, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketamine - Midazolam arm Initial IV Ketamine of 0.5mg/kg with IV Midazolam 0.02mg/kg given over 1 minute. If depth of sedation not adequate, to give another bolus of IV ketamine 0.25mg/kg after 2 minutes with IV Midazolam 0.01mg/kg. If depth of sedation not adequate, to give another bolus of IV Ketamine 0.25mg/kg after 2 minutes and IV Midazolam 0.01mg/kg. Failure of sedation: inadequate sedation for the intention to treat: patient will be arranged for MAC (monitored anaesthesia care) with anaesthesia team	Drug: Ketamine Administration described in arm/ group description Other Names: KETAMINE- MIDAZOLAM Drug: Midazolam Administration described in arm/ group description Other Names: KETAMINE-MIDAZOLAM
Active Comparator: Midazolam - Pethidine arm Initial IV Midazolam 0.05mg/kg given over 1 minute with IV Pethidine 0.7mcg/kg. If depth of sedation not If adequate, to give another bolus of IV Midazolam 0.02mg/kg after 2 minutes and IV Pethidine 0.7mcg/kg. If depth of sedation not adequate, to give another bolus of IV Midazolam 0.02mg/kg after 2 minutes. Failure of sedation: inadequate sedation for the intention to treat: patient will be arranged for MAC (monitored anaesthesia care) with anaesthesia team.	Drug: Midazolam Administration described in arm/ group description Other Names: KETAMINE-MIDAZOLAM Drug: Pethidin Administration described in arm/ group description Other Names: MIDAZOLAM-PETHIDIN

Arm

Intervention/Treatment

Experimental: Ketamine - Midazolam arm

Initial IV Ketamine of 0.5mg/kg with IV Midazolam 0.02mg/kg given over 1 minute. If depth of sedation not adequate, to give another bolus of IV ketamine 0.25mg/kg after 2 minutes with IV Midazolam 0.01mg/kg. If depth of sedation not adequate, to give another bolus of IV Ketamine 0.25mg/kg after 2 minutes and IV Midazolam 0.01mg/kg. Failure of sedation: inadequate sedation for the intention to treat: patient will be arranged for MAC (monitored anaesthesia care) with anaesthesia team

Drug: Ketamine

Administration described in arm/ group description

Other Names:

KETAMINE- MIDAZOLAM

Drug: Midazolam

Administration described in arm/ group description

Other Names:

KETAMINE-MIDAZOLAM

Active Comparator: Midazolam - Pethidine arm

Initial IV Midazolam 0.05mg/kg given over 1 minute with IV Pethidine 0.7mcg/kg. If depth of sedation not If adequate, to give another bolus of IV Midazolam 0.02mg/kg after 2 minutes and IV Pethidine 0.7mcg/kg. If depth of sedation not adequate, to give another bolus of IV Midazolam 0.02mg/kg after 2 minutes. Failure of sedation: inadequate sedation for the intention to treat: patient will be arranged for MAC (monitored anaesthesia care) with anaesthesia team.

Drug: Midazolam

Administration described in arm/ group description

Other Names:

KETAMINE-MIDAZOLAM

Drug: Pethidin

Administration described in arm/ group description

Other Names:

MIDAZOLAM-PETHIDIN

Outcome Measures

Primary Outcome Measures

To evaluate the efficacy of Ketamine- Midazolam as a sedative agent in ERCP in terms of sedation failure rate. [Evaluated at specific timepoints during the procedure which are: introduction of scope, canulation of bile duct, during sphincerotomy, trawling of stones, removal of stent and removal of scope]
Sedation failure rate is defined as inability of the sedation used to adequately sedate a patient for initiation and completion of procedure using ramsay sedation scale where the scale is 1 to 6, where higher score is better. Score of 1 is determined as sedation failure.

Secondary Outcome Measures

To compare pre and post procedure mean arterial pressure (MAP) [Measured at specific time-pointswhich are: pre-sedation, 2 minutes after initiation of sedation and 5 minutes after the procedure is completed]
To detect if there are changes in MAP calculated from participants blood pressure readings
To compare surgeon satisfaction in terms of sedation quality between both arms using a likert scale of 1 to 5 where a higher score is better [Single point asessment at the end of the procedure]
Measured using likert scale
To compare participant satisfaction in terms of procedure experience between both groups using likert scale of 1 to 10 where the higher score is better [Single point asessment at 2 hours after completion of procedure]
Measured using likert scale
To compare the number of participants that developed an adverse event that led to abandonment of procedure [Evaluated at specific timepoints during the procedure which are: introduction of scope, canulation of bile duct, during sphincerotomy, trawling of stones, removal of stent and removal of scope]
Adverse event by monitoring patient vital signs including blood pressure, pulse rate, oxygen saturation and procedure will be abandoned if the parameters reach a pre-set cut-off point. Systolic blood pressure <90mmHg or >180mmHg, Pulse rate of <60/min or >150/min and oxygen saturation <95% despite supplemental oxygen therapy via nasal canula.
To compare the depth of sedation [Evaluated at specific timepoints during the procedure whch are: introduction of scope, canulation of bile duct, during sphincerotomy, trawling of stones, removal of stent and removal of scope]
The depth of sedation is evaluated using ramsay sedation scale where the scale is 1 to 6, where higher score is better

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults > 18 years old which able to give valid consent
Patient planned for ERCP (either emergency or elective)
American Society of Anaesthesiologist (ASA) score of I-III

Exclusion Criteria:

Known hypersensitivity towards Ketamine or Midazolam
Increased intracranial pressure, acute stroke (<3 months), intracranial haemorrhage (<3 months)
Severe hypertension (BP>170/110) and tachycardia (Heart rate >110)
Acute myocardial infarction, acute coronary syndrome (< 6 months)
Tachyarrhythmia
Pregnancy
Intravenous drug user (IVDU) or substance abuse patient
History of hallucination
Child's Pugh class C