Continuous infusion of remimazolam for intraoperative sedation as a safe and effective option: a prospective clinical study.
Phase 4
- Conditions
- Procedural or intraoperative sedation.Anaesthesiology - Anaesthetics
- Registration Number
- ACTRN12623000133639
- Lead Sponsor
- Antonia Kustura, MD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Adult patients between 18 and 80 years of age, ASA class I, II and III, scheduled for elective procedural sedation or sedation with regional anaesthesia.
Exclusion Criteria
Exclusion criteria are age under 18 or over 80, allergy to any of the drugs used, body mass index (BMI) under 18 or over 30, patients with psychiatric diagnoses, and patient refusal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is to determine the necessary range of continuous dose of remimazolam (mg/kg/h) for procedural sedation or sedation with regional anaesthesia. Sedation will be determined by evaluation of BIS, MOAA/S and RASS scores during procedure. All measurements and the dose of remimazolam will be assessed together as a composite primary outcome.[The primary outcome measurements will be assessed every 5 minutes from the start of sedation till complete recovery of consciousness.]
- Secondary Outcome Measures
Name Time Method Side effects registered during continuous infusion of remimazolam will be assessed by standard monitoring. Hypotension will be assessed using sphygmomanometer, bradycardia will be assessed with ECG monitoring and drop in saturation will be assessed using pulse oximeter.[Blood pressure measurements will be assessed every 5 minutes from the start of sedation till complete recovery of consciousness. Heart rate and saturation measurements will be assessed continuously from the start of sedation till complete recovery of consciousness. ]