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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

Tracking Information
First Submitted Date  ICMJE August 10, 2016
First Posted Date  ICMJE August 25, 2016
Last Update Posted Date August 22, 2017
Study Start Date  ICMJE January 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2016)
  • Depth of Sedation [ Time Frame: Intraoperative ]
    Number of breakthrough doses necessary to achieve RASS score between -3 and -1
  • Respiratory depression [ Time Frame: Intraoperative ]
    Use of supplemental oxygen flow greater than 2L/min or endotracheal intubation for mechanical ventilation
  • Bradycardia [ Time Frame: Intraoperative ]
    Heart Rate < 50 heartbeats per minute
  • Hypotension [ Time Frame: Intraoperative ]
    Mean Arterial Pressure < 55mmHg
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2016)
  • Residual Sedation [ Time Frame: Up to 2 hours after surgery ]
    RASS score < -1 in Post Anesthesia Care Unit
  • Shivering [ Time Frame: Up to 2 hours after end of surgery ]
    Self-described by the patient
  • Pain [ Time Frame: 2 days ]
    Pain, described by the patient, according to the Analog Scale. Necessity of breakthrough doses of analgesics.
  • Quality of Sleep [ Time Frame: 2 days ]
    Self-described.
  • Delirium [ Time Frame: 2 days ]
    Incidence of Delirium according to CAM-ICU algorithm
  • Length of Hospital Stay [ Time Frame: Until Discharge, up to 30 days ]
    Length of time between surgery and discharge from Hospital, in days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine vs Midazolam for Intraoperative Sedation
Official Title  ICMJE Dex vs Dazzle: Dexmedetomidine vs Midazolam for Intraoperative Sedation
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,

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Failed Moderate Sedation During Procedure
  • Minimally Conscious State
Intervention  ICMJE
  • Drug: Dexmedetomidine
  • Drug: Midazolam
Study Arms  ICMJE
  • 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.
    Intervention: 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
    Intervention: Drug: Midazolam
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2016)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02878837
Other Study ID Numbers  ICMJE IAMSPE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party João manoel Silva Junior, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Study Sponsor  ICMJE Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP