Dexmedetomidine vs Midazolam for Intraoperative Sedation
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|ClinicalTrials.gov Identifier: NCT02878837|
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : August 22, 2017
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|
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 (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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
- 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
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
|Hospital do Servidor Publico Estadual|
|Sao Paulo, Sao Paulo SP, Brazil, 04039-901|