Hospital do Servidor Publico Estadual
São Paulo, Sao Paulo SP, 04039-901, Brazil
NCT Number: NCT02878837
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
São Paulo, Sao Paulo SP, 04039-901, Brazil
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,
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Intraoperative
Number of breakthrough doses necessary to achieve RASS score between -3 and -1
Time frame: Intraoperative
Use of supplemental oxygen flow greater than 2L/min or endotracheal intubation for mechanical ventilation
Time frame: Intraoperative
Heart Rate < 50 heartbeats per minute
Time frame: Intraoperative
Mean Arterial Pressure < 55mmHg
Time frame: Up to 2 hours after surgery
RASS score < -1 in Post Anesthesia Care Unit
Time frame: Up to 2 hours after end of surgery
Self-described by the patient
Time frame: 2 days
Pain, described by the patient, according to the Analog Scale. Necessity of breakthrough doses of analgesics.
Time frame: 2 days
Self-described.
Time frame: 2 days
Incidence of Delirium according to CAM-ICU algorithm
Time frame: Until Discharge, up to 30 days
Length of time between surgery and discharge from Hospital, in days
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Other
Dex vs Dazzle: Dexmedetomidine vs Midazolam for Intraoperative Sedation
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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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