Failed Moderate Sedation During Procedure, Minimally Conscious State
Conditions
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 description
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,
Interventions
DRUGDexmedetomidine
DRUGMidazolam
Sponsors
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depth of Sedation | Intraoperative | Number of breakthrough doses necessary to achieve RASS score between -3 and -1 |
| Respiratory depression | Intraoperative | Use of supplemental oxygen flow greater than 2L/min or endotracheal intubation for mechanical ventilation |
| Bradycardia | Intraoperative | Heart Rate \< 50 heartbeats per minute |
| Hypotension | Intraoperative | Mean Arterial Pressure \< 55mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual Sedation | Up to 2 hours after surgery | RASS score \< -1 in Post Anesthesia Care Unit |
| Delirium | 2 days | Incidence of Delirium according to CAM-ICU algorithm |
| Shivering | Up to 2 hours after end of surgery | Self-described by the patient |
| Length of Hospital Stay | Until Discharge, up to 30 days | Length of time between surgery and discharge from Hospital, in days |
| Pain | 2 days | Pain, described by the patient, according to the Analog Scale. Necessity of breakthrough doses of analgesics. |
| Quality of Sleep | 2 days | Self-described. |
Countries
Brazil
Outcome results
None listed