Comparison of the sedative effects of midazolam and remimazolam in spinal anesthesia patients: a multicenter clinical trial

Comparison of the sedative effects of midazolam and remimazolam (bifavo injection) in spinal anesthesia patients: a multicenter clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007582

Enrollment

140

Registered

2022-07-28

Start date

2022-09-01

Completion date

Unknown

Last updated

2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In the midazolam group, 0.05 mg/kg is administered as a loading dose over 1 minute and continuous infusion of 0.03–0.2 mg/kg/h is administered to maintain the Bispectral Index (BIS) of 60–80 du

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults 18 years of age or older who are scheduled to undergo spinal anesthesia for orthopedic surgery within 1 hour

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Blood pressure;heart rate;Bispectral index;hypotension;bradycardia;decrease in oxygen saturation;Agitation;Postoperative nausea vomiting;Hiccup	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Suk Kwon

Hallym University Medical Center- Chuncheon

gettys@naver.com+82-33-240-5000

Outcome results