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

NCT ID: NCT05651399

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-26

Study Completion Date

2023-06-14

Brief Summary

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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.

Detailed Description

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Conditions

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Remimazolam Propofol Orthopedic Procedures Sedatives Anesthesia, Spinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Remimazolam

A maintenance dose of remimazolam is administered for sedation

Group Type ACTIVE_COMPARATOR

Remimazolam

Intervention Type DRUG

Patients receive remimazolam at a rate of 1 mg/kg/hr. When a patient's MOAA/S reaches 3 or less, the rate of remomazolam is maintained at a rate between 0.3 mg/kr/hr and 1.0 mg/kg/hr until the end of surgery.

Propofol

A maintenance dose of propofol is administered for sedation

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion.

Interventions

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Remimazolam

Patients receive remimazolam at a rate of 1 mg/kg/hr. When a patient's MOAA/S reaches 3 or less, the rate of remomazolam is maintained at a rate between 0.3 mg/kr/hr and 1.0 mg/kg/hr until the end of surgery.

Intervention Type DRUG

Propofol

Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hajung Kim

Clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2021-1713

Identifier Type: -

Identifier Source: org_study_id

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