Dexmedetomidine vs Midazolam for Intraoperative Sedation

Study Overview
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Brief Summary
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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
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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,

Official Title
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Dex vs Dazzle: Dexmedetomidine vs Midazolam for Intraoperative Sedation

Conditions
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Failed Moderate Sedation During Procedure, Minimally Conscious State

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DEX<br>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. | Drug: Dexmedetomidine<br> <br> |
| Active Comparator: MDZ<br>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 | Drug: Midazolam<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of Sedation | Number of breakthrough doses necessary to achieve RASS score between -3 and -1 | Intraoperative | 
| Respiratory depression | Use of supplemental oxygen flow greater than 2L/min or endotracheal intubation for mechanical ventilation | Intraoperative | 
| Bradycardia | Heart Rate < 50 heartbeats per minute | Intraoperative | 
| Hypotension | Mean Arterial Pressure < 55mmHg | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual Sedation | RASS score < -1 in Post Anesthesia Care Unit | Up to 2 hours after surgery | 
| Shivering | Self-described by the patient | 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. | 2 days | 
| Quality of Sleep | Self-described. | 2 days | 
| Delirium | Incidence of Delirium according to CAM-ICU algorithm | 2 days | 
| Length of Hospital Stay | Length of time between surgery and discharge from Hospital, in days | Until Discharge, up to 30 days |