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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05651399
Other study ID # 2021-1713
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 26, 2022
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source Asan Medical Center
Contact Hyeokseong Park
Phone 01051401323
Email phsung509@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 78
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 64 Years
Eligibility 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


Intervention

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.
Propofol
Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion.

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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