Back to resultsComparison in Frequency of Hypotension Between Remimazolam and Propofol in Hip Surgery
Primary Purpose
Remimazolam, Propofol, Orthopedic Procedures
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remimazolam
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Remimazolam
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
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Remimazolam
Propofol
Arm Description
A maintenance dose of remimazolam is administered for sedation
A maintenance dose of propofol is administered for sedation
Outcomes
Primary Outcome Measures
Frequency of hypotension during surgery (1hour)
mean blood pressure less than 65mmHg
Secondary Outcome Measures
Frequency of hypotension during surgery
mean blood pressure less than 65mmHg
Total administered phenylephrine
total dose of phenylephrine administered during surgery
Fluid volume
Total amount of fluid infused during surgery
Number of hypotensive episodes in the post-anesthesia care unit after surgery
mean blood pressure less than 65mmHg
Complications after surgery
Cardiovascular/neurological/respiratory complications, delirium, impaired renal function, or postoperative nausea and vomiting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05651399
Brief Title
Comparison in Frequency of Hypotension Between Remimazolam and Propofol in Hip Surgery
Official Title
Comparison in Frequency of Hypotension During Sedation of Propofol and Remimazolam in Spinal Anesthesia in Hip Surgery Patients: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 26, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Remimazolam, Propofol, Orthopedic Procedures, Sedatives, Anesthesia, Spinal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remimazolam
Arm Type
Active Comparator
Arm Description
A maintenance dose of remimazolam is administered for sedation
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
A maintenance dose of propofol is administered for sedation
Intervention Type
Drug
Intervention Name(s)
Remimazolam
Intervention Description
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
Intervention Name(s)
Propofol
Intervention Description
Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion.
Primary Outcome Measure Information:
Title
Frequency of hypotension during surgery (1hour)
Description
mean blood pressure less than 65mmHg
Time Frame
up to 1 hour after initiation of drug infusion
Secondary Outcome Measure Information:
Title
Frequency of hypotension during surgery
Description
mean blood pressure less than 65mmHg
Time Frame
Throughout the surgery
Title
Total administered phenylephrine
Description
total dose of phenylephrine administered during surgery
Time Frame
Throughout the surgery
Title
Fluid volume
Description
Total amount of fluid infused during surgery
Time Frame
Throughout the surgery
Title
Number of hypotensive episodes in the post-anesthesia care unit after surgery
Description
mean blood pressure less than 65mmHg
Time Frame
up to 1 hour after postanesthesia care unit entry
Title
Complications after surgery
Description
Cardiovascular/neurological/respiratory complications, delirium, impaired renal function, or postoperative nausea and vomiting
Time Frame
up to 7 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyeokseong Park
Phone
01051401323
Email
phsung509@gmail.com
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hajung Kim, M.D., Ph.D.
Email
alexakim06@gmail.com
First Name & Middle Initial & Last Name & Degree
Hyeokseong Park, M.D.
12. IPD Sharing Statement
Learn more about this trial
Comparison in Frequency of Hypotension Between Remimazolam and Propofol in Hip Surgery
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