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Dexmedetomidine vs Midazolam for Intraoperative Sedation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02878837
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
João manoel Silva Junior, 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.


Condition or disease Intervention/treatment Phase
Failed Moderate Sedation During Procedure Minimally Conscious State Drug: Dexmedetomidine Drug: Midazolam Phase 4

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,

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dex vs Dazzle: Dexmedetomidine vs Midazolam for Intraoperative Sedation
Study Start Date : January 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878837


Locations
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Brazil
Hospital do Servidor Publico Estadual
Sao Paulo, Sao Paulo SP, Brazil, 04039-901
Sponsors and Collaborators
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: João manoel Silva Junior, Director, Department of Anesthesiology, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
ClinicalTrials.gov Identifier: NCT02878837    
Other Study ID Numbers: IAMSPE
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Persistent Vegetative State
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous