Dexmedetomidine vs Midazolam for Intraoperative Sedation

August 17, 2017 updated by: João manoel Silva Junior, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Dex vs Dazzle: Dexmedetomidine vs Midazolam for Intraoperative Sedation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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,

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo SP
      • Sao Paulo, Sao Paulo SP, Brazil, 04039-901
        • Hospital do Servidor Publico Estadual

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergoing surgery under regional anesthesia

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: DEX
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.
Drug: Dexmedetomidine
ACTIVE_COMPARATOR: MDZ
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
Drug: Midazolam

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 20, 2016

First Posted (ESTIMATE)

August 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAMSPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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