Comparing Clinical Outcomes Between Ketamine-midazolam and Morphine-midazolam for Continous Sedation in ICU Patients.

Phase 2

Terminated

• Conditions: Critical Illness
• Interventions: Combination Product: Ketamine-Midazolam; Combination Product: Morphine -Midazolam

• Registration Number: NCT03407404
• Lead Sponsor: Makerere University

Brief Summary

A prospective, double-blinded, multicenter randomized control trial. All critically ill patients above 12 years of age requiring continuous sedation for \>24hrs in the ICU will be screened and those meeting selection criteria (and consented) will be enrolled into the study.

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Detailed Description

165 participants shall be consecutively randomized into either sedation with ketamine-midazolam or morphine-midazolam group using a block sequence technique; group concealed in brown envelopes. Blinding will be at patient/next of kin level as well as investigator/data collector level.

Enrolled subjects shall be followed up for treatment history, co-morbidities and related data will be collected, results analyzed and study findings will be availed to ICU physicians and Ministry of health to guide treatment considerations and for health care planning.

Data shall be collected using a standardized questionnaire by trained research assistants. It will be double entered into Epidata and exported to STATA version 12.0 for analysis. Continuous variables will be expressed as means and standard deviations, while categorical data will be expressed as frequencies with their respective percentages. Linear regression and logistic regression used to analyse primary outcomes, as well as multivariate analysis to detect associations.

Study Timeline

• Study First Submitted: 2017-06-05
• Study Start: 2017-10-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-23
• Primary Completion: 2019-06-15
• Study Completion: 2019-07-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

1. Age >12years of age.
2. Anticipated need for sedation for >24hours.

Exclusion Criteria

1. Hypertensive crisis i.e. sustained SBP >200mmHg/DBP>110mmHg
2. Status epilepticus
3. Ischemic heart disease and severe LV dysfunction
4. Persistent tachyarrythmias
5. History of mental illness
6. Hypersensitivity to ketamine, morphine or midazolam.
7. Tetanus -due to the muscle rigidity that may be caused by ketamine. Reasons for exclusions 1 to 4; Ketamine stimulates the sympathetic nervous system causing transient increase in myocardial work and blood pressure and has psychoactive effects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine-midazolam	Ketamine-Midazolam	Continous intravenous sedation with a colorless drug mixture in 50ml syringe containing 900mg ketamine and 36mg midazolam.
Morphine-Midazolam	Morphine -Midazolam	Continous intravenous sedation with a colourless drug mixture in 50ml syringes containing 54mg morphine and 36mg midazolam.

Primary Outcome Measures

Name	Time	Method
incidence of hypotension	14 days	incidence of hypotension requiring vasopressor support.
duration of mechanical ventilation	14 days	in hours from start of mechanical ventialtion
incidence of delirium	14 days	assessed daily with the CAM-ICU score

Secondary Outcome Measures

Name	Time	Method
mortality rate	within 14 days	number of deaths in each study arm
ICU length of stay	14 days	length of stay in the intensive care unit from enrollment.

Trial Locations

Locations (1)

Mulago National Referral Hospital ICU; 🇺🇬 Kampala, Central, Uganda