Comparison of the sedative effects of midazolam and remimazolam in spinal anesthesia patients: a multicenter clinical trial
Not Applicable
- Conditions
- Not Applicable
- Registration Number
- KCT0007582
- Lead Sponsor
- Hallym University Medical Center- Chuncheon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
Adults 18 years of age or older who are scheduled to undergo spinal anesthesia for orthopedic surgery within 1 hour
Exclusion Criteria
a. Those taking antidepressants, antispasmodics, opioid analgesics, and antiemetics before surgery
b. Patients with ASA-PS 3 or higher
c. BMI 30 or higher
d. History of hypersensitivity to benzodiazepines and flumazenil
e. Patients with other contraindications to each drug.
f. patient's refusal
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time taken to drop below BIS 80 after initiation of continuous infusion;Time taken to BIS 90 or higher after discontinuation of continuous infusion;Time from start of continuous infusion to Modified Observer’s Assessment of Alertness/Sedation score <=3;Time for the Modified Observer’s Assessment of Alertness/Sedation score to reach 5 points after continuous infusion is stopped
- Secondary Outcome Measures
Name Time Method Blood pressure;heart rate;Bispectral index;hypotension;bradycardia;decrease in oxygen saturation;Agitation;Postoperative nausea vomiting;Hiccup