Clinical Trial: Dexmedetomidine vs Midazolam for Intraoperative Sedation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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,

Sponsor: Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Current Primary Outcome:

• 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: Same as current

Current Secondary Outcome:

• 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: Same as current

Information By: Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Dates:
Date Received: August 10, 2016
Date Started: January 2016
Date Completion:
Last Updated: August 20, 2016
Last Verified: August 2016