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Completed

NCT Number: NCT02878837

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.

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Key information

About this study

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,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

midazolam

Drug

Primary outcomes

  1. Depth of Sedation

    Time frame: Intraoperative

    Number of breakthrough doses necessary to achieve RASS score between -3 and -1

  2. Respiratory depression

    Time frame: Intraoperative

    Use of supplemental oxygen flow greater than 2L/min or endotracheal intubation for mechanical ventilation

  3. Bradycardia

    Time frame: Intraoperative

    Heart Rate < 50 heartbeats per minute

  4. Hypotension

    Time frame: Intraoperative

    Mean Arterial Pressure < 55mmHg

Secondary outcomes

  1. Residual Sedation

    Time frame: Up to 2 hours after surgery

    RASS score < -1 in Post Anesthesia Care Unit

  2. Shivering

    Time frame: Up to 2 hours after end of surgery

    Self-described by the patient

  3. Pain

    Time frame: 2 days

    Pain, described by the patient, according to the Analog Scale. Necessity of breakthrough doses of analgesics.

  4. Quality of Sleep

    Time frame: 2 days

    Self-described.

  5. Delirium

    Time frame: 2 days

    Incidence of Delirium according to CAM-ICU algorithm

  6. Length of Hospital Stay

    Time frame: Until Discharge, up to 30 days

    Length of time between surgery and discharge from Hospital, in days

Sponsors and collaborators

Lead sponsor

Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Other

Registry information

Official study title

Dex vs Dazzle: Dexmedetomidine vs Midazolam for Intraoperative Sedation

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 25, 2016
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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