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

February 24, 2025 updated by: Hajung Kim, Asan Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Remimazolam
A maintenance dose of remimazolam is administered for sedation
Drug: 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.
Active Comparator: Propofol
A maintenance dose of propofol is administered for sedation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of hypotension during surgery (1hour)
Time Frame: up to 1 hour after initiation of drug infusion
mean blood pressure less than 65mmHg
up to 1 hour after initiation of drug infusion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2022

Primary Completion (Actual)

June 14, 2023

Study Completion (Actual)

June 14, 2023

Study Registration Dates

First Submitted

August 12, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-1713

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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