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

Phase 4

Completed

• Conditions: Sedatives; Anesthesia, Spinal; Remimazolam; Propofol; Orthopedic Procedures
• Interventions: Drug: Remimazolam; Drug: Propofol

• Registration Number: NCT05651399
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-15
• Study Start: 2022-12-26
• Primary Completion: 2023-06-14
• Study Completion: 2023-06-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam	Remimazolam	A maintenance dose of remimazolam is administered for sedation
Propofol	Propofol	A maintenance dose of propofol is administered for sedation

Primary Outcome Measures

Name	Time	Method
Frequency of hypotension during surgery (1hour)	up to 1 hour after initiation of drug infusion	mean blood pressure less than 65mmHg

Secondary Outcome Measures

Name	Time	Method
Frequency of hypotension during surgery	Throughout the surgery	mean blood pressure less than 65mmHg
Total administered phenylephrine	Throughout the surgery	total dose of phenylephrine administered during surgery
Fluid volume	Throughout the surgery	Total amount of fluid infused during surgery
Number of hypotensive episodes in the post-anesthesia care unit after surgery	up to 1 hour after postanesthesia care unit entry	mean blood pressure less than 65mmHg
Complications after surgery	up to 7 days after surgery	Cardiovascular/neurological/respiratory complications, delirium, impaired renal function, or postoperative nausea and vomiting

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of