Comparison in Frequency of Hypotension Between Remimazolam and Propofol in Hip Surgery
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2022
CompletedFirst Posted
Study publicly available on registry
December 15, 2022
CompletedStudy Start
First participant enrolled
December 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2023
CompletedFebruary 26, 2025
February 1, 2025
6 months
August 12, 2022
February 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of hypotension during surgery (1hour)
mean blood pressure less than 65mmHg
up to 1 hour after initiation of drug infusion
Secondary Outcomes (5)
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
Study Arms (2)
Remimazolam
ACTIVE COMPARATORA maintenance dose of remimazolam is administered for sedation
Propofol
ACTIVE COMPARATORA maintenance dose of propofol is administered for sedation
Interventions
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.
Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion.
Eligibility Criteria
You may qualify if:
- ASA physical status 1-3
- Patients scheduled for hip joint surgery under spinal anesthesia and sedation with propofol or remimzolam
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, 05505, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical assistant professor
Study Record Dates
First Submitted
August 12, 2022
First Posted
December 15, 2022
Study Start
December 26, 2022
Primary Completion
June 14, 2023
Study Completion
June 14, 2023
Last Updated
February 26, 2025
Record last verified: 2025-02