Minimally Conscious State Clinical Trial
Official title:
Dex vs Dazzle: Dexmedetomidine vs Midazolam for Intraoperative Sedation
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,
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02288533 -
Transcranial Direct Current Stimulation Effects in Patients With Chronic Consciousness Disorders
|
N/A | |
| Completed |
NCT03494218 -
Reliability and Validity of the NCS (NCS-R)-Chinese Version
|
N/A | |
| Recruiting |
NCT02591069 -
Vagal Nerve Stimulation in Coma Patients
|
N/A | |
| Active, not recruiting |
NCT03826407 -
Development of a Point of Care System for Automated Coma Prognosis
|
||
| Completed |
NCT04687553 -
Validation of the Chinese Version of the SECONDs
|
N/A | |
| Completed |
NCT05536921 -
Eye Tracking Technology in the Diagnosis of Neurological Patients
|
||
| Completed |
NCT03126929 -
Further Psychometric Data for the Reliability and the Diagnostic Validity of CRS-R
|
N/A | |
| Completed |
NCT03732092 -
The Effects of Olfactory Stimulation on Diagnosis and Prognosis of DOC Patients
|
||
| Completed |
NCT03508336 -
The Initiation of Swallowing Can Indicate the Prognosis of DOC
|
||
| Completed |
NCT04921683 -
The Use of LIFUP in Chronic Disorders of Consciousness
|
N/A | |
| Terminated |
NCT03367078 -
tDCS in Patients With Disorder of Consciousness Due to Severe Acquired Brain Injury
|
||
| Recruiting |
NCT04798456 -
Aiming for a Better Understanding and Improvement of the Diagnosis and Prognosis of Patients With Disorders of Consciousness Through Multimodal Observations
|
||
| Not yet recruiting |
NCT04248946 -
Neural, Behavioural, and Clinical Effects of tDCS in PDOC; Feasibility Study
|
N/A | |
| Completed |
NCT01820923 -
Transcranial Brain Stimulation in Vegetative State Patients
|
N/A | |
| Recruiting |
NCT01027572 -
Thalamic Stimulation of Patients in Vegetative or Minimally Conscious State
|
Phase 2 | |
| Completed |
NCT00557076 -
The Efficacy of Familiar Voice Stimulation During Coma Recovery
|
N/A | |
| Recruiting |
NCT03910959 -
Therapeutic Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State
|
N/A | |
| Recruiting |
NCT04010838 -
Spinal Cord Stimulation in Patients With Disorders of Consciousness
|
N/A | |
| Completed |
NCT04139239 -
Diagnostic Accuracy of the Vegetative and Minimally Conscious State
|
||
| Recruiting |
NCT03007784 -
Two Intensities of Transcranial Direct Current Stimulation to Improve Consciousness in Severely Brain Injured Patients
|
Phase 3 |