Comparison in Frequency of Hypotension Between Remimazolam and Propofol in Hip Surgery

Asan Medical Center

Status and phase: Completed; Phase 4

Conditions: Remimazolam; Orthopedic Procedures; Propofol; Anesthesia, Spinal; Sedatives

Treatments: Drug: Propofol; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05651399

2021-1713

Details and patient eligibility

About

The purpose of this study is to compare the incidence of hypotension between remimazolam and propofol for intraoperative sedation in patients undergoing hip surgery with spinal anesthesia.

Enrollment: 78 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA physical status 1-3
• Patients scheduled for hip joint surgery under spinal anesthesia and sedation with propofol or remimzolam

Exclusion criteria

• Patients who refuse to participate in this study
• Patients with uncontrolled high blood pressure, hyperthyroidism, dementia in the inability to communicate, or symptomatic coronary artery disease
• Patients with an allergy to propofol, fentanyl, or bupivacaine
• Patients contraindicated for spinal anesthesia, such as coagulopathy, severe aortic stenosis/mitral stenosis, and active infection on lumbar region
• Patients judged to be inappropriate for this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Remimazolam

Active Comparator group

Description:

A maintenance dose of remimazolam is administered for sedation

Treatment:

Drug: Remimazolam

Propofol

Active Comparator group

Description:

A maintenance dose of propofol is administered for sedation

Treatment:

Drug: Propofol