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

Asan Medical Center78 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Remimazolam Propofol Orthopedic Procedures Sedatives Anesthesia, Spinal

Interventions

RemimazolamDRUG

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.

PropofolDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Frequency of hypotension during surgery (1hour)

mean blood pressure less than 65mmHg

Time frame: up to 1 hour after initiation of drug infusion

Secondary Outcomes

Frequency of hypotension during surgery

mean blood pressure less than 65mmHg

Time frame: Throughout the surgery

Total administered phenylephrine

total dose of phenylephrine administered during surgery

Time frame: Throughout the surgery

Fluid volume

Total amount of fluid infused during surgery

Time frame: Throughout the surgery

Number of hypotensive episodes in the post-anesthesia care unit after surgery

mean blood pressure less than 65mmHg

Time frame: up to 1 hour after postanesthesia care unit entry

Complications after surgery

Cardiovascular/neurological/respiratory complications, delirium, impaired renal function, or postoperative nausea and vomiting

Time frame: up to 7 days after surgery

Data from ClinicalTrials.gov

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