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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Hospital do Servidor Publico Estadual
São Paulo, Sao Paulo SP, Brazil
Depth of Sedation
Number of breakthrough doses necessary to achieve RASS score between -3 and -1
Time frame: Intraoperative
Respiratory depression
Use of supplemental oxygen flow greater than 2L/min or endotracheal intubation for mechanical ventilation
Time frame: Intraoperative
Bradycardia
Heart Rate \< 50 heartbeats per minute
Time frame: Intraoperative
Hypotension
Mean Arterial Pressure \< 55mmHg
Time frame: Intraoperative
Residual Sedation
RASS score \< -1 in Post Anesthesia Care Unit
Time frame: Up to 2 hours after surgery
Shivering
Self-described by the patient
Time frame: Up to 2 hours after end of surgery
Pain
Pain, described by the patient, according to the Analog Scale. Necessity of breakthrough doses of analgesics.
Time frame: 2 days
Quality of Sleep
Self-described.
Time frame: 2 days
Delirium
Incidence of Delirium according to CAM-ICU algorithm
Time frame: 2 days
Length of Hospital Stay
Length of time between surgery and discharge from Hospital, in days
Time frame: Until Discharge, up to 30 days
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