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

Critical Illness Clinical Trial

— KeMiMof  

Official title:

Ketamine-Midazolam Versus Morphine-Midazolam for Continous Patient Sedation in Intensive Care Units in Uganda. A Randomised Controlled Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03407404
• Other study ID #: 2015/HD07/1275U
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: October 22, 2017
• Est. completion date: July 30, 2019

Study information

• Verified date: August 2019
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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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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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 124
• Est. completion date: July 30, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Combination Product:
• Ketamine-Midazolam
Continous intravenous sedation with 36mg of Midazolam and 900mg of Ketamine mixed in 50ml syringes as long as patient still requires sedation.
• Morphine -Midazolam
Continous intravenous sedation with 54mg of Morphine Sulphate and 36mg of midazolam mixed in 50ml syringes as long as participant still requires sedation.

Locations

Country	Name	City	State
Uganda	Mulago National Referral Hospital ICU	Kampala	Central

Sponsors (2)

Lead Sponsor	Collaborator
Makerere University	THRiVE

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of mechanical ventilation	in hours from start of mechanical ventialtion	14 days
Primary	incidence of hypotension	incidence of hypotension requiring vasopressor support.	14 days
Primary	incidence of delirium	assessed daily with the CAM-ICU score	14 days
Secondary	ICU length of stay	length of stay in the intensive care unit from enrollment.	14 days
Secondary	mortality rate	number of deaths in each study arm	within 14 days