search
Back to results

Comparison 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
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Remimazolam

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 12, 2022
Last Updated
February 3, 2023
Sponsor
Asan Medical Center
search

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

We'll reach out to this number within 24 hrs