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

Study Overview
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Brief Summary
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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.

Official Title
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Comparison in Frequency of Hypotension During Sedation of Propofol and Remimazolam in Spinal Anesthesia in Hip Surgery Patients: a Randomized Controlled Clinical Trial

Conditions
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Remimazolam, Propofol, Orthopedic Procedures, Sedatives, Anesthesia, Spinal

Intervention / Treatment
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* Drug: Remimazolam
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remimazolam<br>A maintenance dose of remimazolam is administered for sedation | Drug: Remimazolam<br>* 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.<br>|
| Active Comparator: Propofol<br>A maintenance dose of propofol is administered for sedation | Drug: Propofol<br>* Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of hypotension during surgery (1hour) | mean blood pressure less than 65mmHg | up to 1 hour after initiation of drug infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of hypotension during surgery | mean blood pressure less than 65mmHg | Throughout the surgery | 
| Total administered phenylephrine | total dose of phenylephrine administered during surgery | Throughout the surgery | 
| Fluid volume | Total amount of fluid infused during surgery | Throughout the surgery | 
| 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 | 
| Complications after surgery | Cardiovascular/neurological/respiratory complications, delirium, impaired renal function, or postoperative nausea and vomiting | up to 7 days after surgery |