Midazolam Used Alone or Sequential Use of Midazolam and Propofol/Dexmedetomidine in Mechanically Ventilated Patients

NCT02528513 | Unknown Phase 4 DMC

• 1 other identifier: HaxiICU
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate effects, safety and cost of midazolam used alone or sequential use of midazolam and propofol/dexmedetomidine for long-term sedation in critically ill, mechanically ventilated patients.

Conditions

Mechanical Ventilation; Complication; Delirium

Keywords

sedation; Midazolam; Propofol; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Weaning time

  From sedation sequential criteria to extubation, up to 28 days

Secondary Outcomes (4)

• The pharmaceutical costs of sedation

  From sedation drug is used to cessation of sedation up to 28 days.

• The total ICU costs

  From admitted to ICU until ventilation and participants discharged from ICU, up to 28 days.

• The incidence of delirium (patients with diagnosis of delirium/ total patients in each group × 100% )

  From sedation drug is used to cessation of sedation, up to 28 days.

• Sedation satisfaction degree (The total time within target sedation level/total evaluation times ×100% )

  From sedation drug is used to cessation of sedation up to 28 days.

Study Arms (3)

midazolam

EXPERIMENTAL

1. Midazolam is started with an infusion bolus of 0.03-0.30 mg/kg and continuous infusion of 0.03-0.20 mg/kg/h, with the dosage adjusted to achieve the desired level of sedation. 2. After the spontaneous breathing trial safety screen is passed, midazolam will continue to be used for sedation, with the dosage adjusted to achieve the desired level of sedation.

Drug: midazolam; Drug: Fentanyl; Procedure: Procedure:sedation assessment; Procedure: Procedure:Weaning; Drug: midazolam(used for passing the SBT safety screen)

midazolam/propofol

EXPERIMENTAL

1. Midazolam is started with an infusion bolus of 0.03-0.30 mg/kg and continuous infusion of 0.03-0.20 mg/kg/h, with the dosage adjusted to achieve the desired level of sedation. 2. After the spontaneous breathing trial safety screen is passed, midazolam is switched to propofol, which is administered at the maintenance dosage of 0.50-3.00mg/kg/h, with the dosage adjusted to achieve the desired level of sedation.

Drug: midazolam; Drug: Fentanyl; Drug: propofol; Procedure: Procedure:sedation assessment; Procedure: Procedure:Weaning

midazolam/dexmedetomidine

EXPERIMENTAL

1. Midazolam is started with an infusion bolus of 0.03-0.30 mg/kg and continuous infusion of 0.03-0.20 mg/kg/h, with the dosage adjusted to achieve the desired level of sedation. 2. After the spontaneous breathing trial safety screen is passed, midazolam is switched to dexmedetomidine, which is administered at an infusion bolus of 0.5 μg/kg over 10 min (given or not according to patients' condition) and the maintenance dosage of 0.2-0.7ug/kg/h, with the dosage adjusted to achieve the desired level of sedation.

Drug: midazolam; Drug: Fentanyl; Drug: Dexmedetomidine; Procedure: Procedure:sedation assessment; Procedure: Procedure:Weaning

Interventions

midazolam DRUG

Midazolam is started with an infusion bolus of 0.03-0.30 mg/kg and continuous infusion of 0.03-0.20 mg/kg/h, with the dosage adjusted to RASS score (-3 to 0).

Also known as: Liyuxi

midazolam; midazolam/dexmedetomidine; midazolam/propofol

Fentanyl DRUG

Fentanyl is used with bolus dosage of 1-2ug/kg and maintenance dosage of 1-2ug/kg/h, with the dosage adjusted to critical care pain observation tool（CPOT）score(0-1).

midazolam; midazolam/dexmedetomidine; midazolam/propofol

propofol DRUG

After the spontaneous breathing trial safety screen is passed, midazolam is switched to propofol, which is administered at the maintenance dosage of 0.50-3.00mg/kg/h, with the dosage adjusted to RASS score (-2 to 0).

midazolam/propofol

Dexmedetomidine DRUG

After the spontaneous breathing trial safety screen is passed, midazolam is switched to dexmedetomidine, which is administered at an infusion bolus of 0.5μg/kg over 10 min (given or not according to patients' condition) and the maintenance dosage of 0.2-0.7ug/kg/h, with the dosage adjusted to RASS score (-2 to 0).

midazolam/dexmedetomidine

Procedure:sedation assessment PROCEDURE

The nursing staff continuously monitored the sedation depth and adjusted the dosages of sedative and analgesic drugs to maintain the sedation target level. The sedation depth were assessed and recorded every 4 h (or more frequently when indicated).

midazolam; midazolam/dexmedetomidine; midazolam/propofol

Procedure:Weaning PROCEDURE

the respiratory therapists managed patients with a daily interruption of continuous sedation and the spontaneous breathing trial (SBT) protocols daily.

midazolam; midazolam/dexmedetomidine; midazolam/propofol

midazolam(used for passing the SBT safety screen) DRUG

After the spontaneous breathing trial safety screen is passed,in the midazolam group, midazolam will continue to be used for sedation, with the dosage adjusted to RASS score (-2 to 0).

Also known as: Liyuxi

midazolam

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intubated patients;
• Age≥18 years old;
• Anticipated Ventilation and sedation duration of at least 72 hours.

You may not qualify if:

• Allergy to the study drug;
• suspected pregnancy;
• gross obesity;
• Extremely unstable of circulatory system, such as systolic blood pressure less than 90 mm Hg despite plasma volume expansion and continuous infusions of vasopressors before the start of study drug infusion;
• Uncontrolled abnormal hypertension, such as systolic blood pressure more than 180 mmHg or diastolic more than105 mmHg;
• Heart rate less than 50 bpm;
• Second or third degree heart block;
• moribund state;
• history of alcoholism or intake of anti-anxiety drugs or hypnotics;
• chronic renal failure;
• coma by cranial trauma or neurosurgery or unknown etiology or epileptic state;
• History of neuromuscular disease;
• unwillingness to provide informed consent by patients or their authorized surrogates following ICU admission.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Department of Critical care medicine of West China Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• Zhou Y, Yang J, Wang B, Wang P, Wang Z, Yang Y, Liang G, Jing X, Jin X, Zhang Z, Deng Y, Hu C, Liao X, Yin W, Tang Z, Tian Y, Tao L, Kang Y. Sequential use of midazolam and dexmedetomidine for long-term sedation may reduce weaning time in selected critically ill, mechanically ventilated patients: a randomized controlled study. Crit Care. 2022 May 3;26(1):122. doi: 10.1186/s13054-022-03967-5.

  PMID: 35505432 DERIVED

MeSH Terms

Conditions

Delirium

Interventions

Midazolam; Fentanyl; Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles

Study Officials

• Y Kang, Dr

  Critical Medicine Department,West China Hospital of Sichuan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zhou Yongfang

Study Record Dates

• First Submitted: August 15, 2015
• First Posted: August 19, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

CN (1)