Dexmedetomidine vs Midazolam for Intraoperative Sedation

Phase 4

Completed

• Conditions: Failed Moderate Sedation During Procedure; Minimally Conscious State
• Interventions: Drug: Dexmedetomidine; Drug: Midazolam

• Registration Number: NCT02878837
• Lead Sponsor: Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Brief Summary

This randomized, open clinical trial sought to compare the use of Midazolam and Dexmedetomidine during surgery in patients under regional anesthesia.

The primary objective was to determine the superiority of either drug during the intraoperative period regarding: 1- Depth of sedation and 2- incidence of complications.

Secondary objectives included the determination of superiority regarding the postoperative period.

For that, patients were randomized into two groups and sedated with either Midazolam or Dexmedetomidine.

Detailed Description

This study was a randomized, open clinical trial.

Patients undergoing surgery under regional (neuraxial or brachial plexus block) anesthesia were randomly assigned into one of two groups.

Patients in one of the groups (called MDZ) were initially sedated with a 0.05mg/Kg bolus dose of Midazolam.

The ones in the other group (called DEX) were initially sedated with a loading dose of 1 µg/Kg of Dexmedetomidine over 10 minutes, followed by continuous infusion at 0.2 to 0.8 µg/Kg/h.

In order to achieve a Richmond Agitation-Sedation Scale (RASS) score between -3 and -1, the following breakthrough doses were used as necessary:

MDZ: 0.02 mg/Kg bolus dose of Midazolam plus 0.5µg/Kg bolus dose of Fentanyl DEX: 0.5µg/Kg bolus dose of Fentanyl

Depth of sedation and incidence of complications were recorded during surgery, in the Post Anesthesia Care Unit (PACU) and in the Ward for two days following surgery,

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-20
• Study First Posted: 2016-08-25
• Primary Completion: 2017-04
• Study Completion: 2017-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Undergoing surgery under regional anesthesia

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Exclusion Criteria

• The presence of any Bradyarrhythmia;
• New York Heart Association (NYHA) Functional Classes III and IV Heart Failure and/or Left Ventricle Ejection Fraction under 30%;
• Respiratory Failure, Glasgow Coma Scale score 8 or under, and Liver Failure - due to the increased risk of sedation in patients with these conditions (d) refusal to participate in the study or withdrawal of consent at any moment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEX	Dexmedetomidine	Patients undergoing surgical procedures under regional anesthesia sedated with a loading dose of 1 µg/Kg of Dexmedetomidine over 10 minutes followed by continuous infusion at 0.2 to 0.8 µg/Kg/h, along with 0.5µg/Kg bolus breakthrough doses of Fentanyl as necessary to achieve a RASS score between -3 and -1.
MDZ	Midazolam	Patients undergoing surgical procedures under regional anesthesia sedated with a 0.05mg/Kg bolus dose of Midazolam, along with 0.02 mg/Kg bolus doses of Midazolam plus 0.5µg/Kg bolus doses of Fentanyl as necessary to achieve a RASS score between -3 and -1

Primary Outcome Measures

Name	Time	Method
Bradycardia	Intraoperative	Heart Rate \< 50 heartbeats per minute
Hypotension	Intraoperative	Mean Arterial Pressure \< 55mmHg
Depth of Sedation	Intraoperative	Number of breakthrough doses necessary to achieve RASS score between -3 and -1
Respiratory depression	Intraoperative	Use of supplemental oxygen flow greater than 2L/min or endotracheal intubation for mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
Shivering	Up to 2 hours after end of surgery	Self-described by the patient
Delirium	2 days	Incidence of Delirium according to CAM-ICU algorithm
Length of Hospital Stay	Until Discharge, up to 30 days	Length of time between surgery and discharge from Hospital, in days
Residual Sedation	Up to 2 hours after surgery	RASS score \< -1 in Post Anesthesia Care Unit
Pain	2 days	Pain, described by the patient, according to the Analog Scale. Necessity of breakthrough doses of analgesics.
Quality of Sleep	2 days	Self-described.

Trial Locations

Locations (1)

Hospital do Servidor Publico Estadual; 🇧🇷 Sao Paulo, Sao Paulo SP, Brazil