Comparison in Frequency of Hypotension During Sedation of Propofol and Remimazolam in Spinal Anesthesia in Hip Surgery Patients: a Randomized Controlled Clinical Trial

Asan Medical Center1 site in 1 country78 target enrollmentDecember 26, 2022

ConditionsRemimazolam Propofol Orthopedic Procedures Sedatives Anesthesia, Spinal

InterventionsRemimazolam Propofol

DrugsRemimazolam Propofol

Overview

Phase: Phase 4
Intervention: Remimazolam
Conditions: Remimazolam
Sponsor: Asan Medical Center
Enrollment: 78
Locations: 1
Primary Endpoint: Frequency of hypotension during surgery (1hour)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 26, 2022

End Date

June 14, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Asan Medical Center

Responsible Party

Principal Investigator

Hajung Kim

Clinical assistant professor

Asan Medical Center

Eligibility Criteria

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

Arms & Interventions

Remimazolam

A maintenance dose of remimazolam is administered for sedation

Intervention: Remimazolam

Propofol

A maintenance dose of propofol is administered for sedation

Intervention: Propofol

Outcomes

Primary Outcomes

Frequency of hypotension during surgery (1hour)

Time Frame: up to 1 hour after initiation of drug infusion

mean blood pressure less than 65mmHg

Secondary Outcomes

Frequency of hypotension during surgery(Throughout the surgery)
Total administered phenylephrine(Throughout the surgery)
Fluid volume(Throughout the surgery)
Number of hypotensive episodes in the post-anesthesia care unit after surgery(up to 1 hour after postanesthesia care unit entry)
Complications after surgery(up to 7 days after surgery)