Hip Fracture
Conditions
Brief summary
Purpose: This study aims to compare the emergence time among three anesthesia regimens: remimazolam, remimazolam with flumazenil, and propofol in elderly patients undergoing hip replacement surgery. Background: Previous studies have shown that flumazenil accelerates emergence time when used with remimazolam. Remimazolam and propofol have comparable emergence times, although remimazolam can be up to 5 minutes longer than propofol.
Interventions
DRUGRemimazolam
In Remimazolam group, the induction dose of remimazolam is 0.3 mg/kg based on previous studies, the maintenance of anesthesia is 0.3-0.7 mg/kg/hr.
DRUGFlumazenil
Immediately after the cessation of remimazolam infusion in PACU(PACU, Postanesthesia care unit), the nurses who are blind to the anesthesia management were asked to administer the flumazenil.
DRUGPropofol
For propofol group, the induction of propofol is 1.5-2.0 mg/kg, followed by the maintenance of propofol infusion with 6-8 mg/kg/hr throughout the surgical procedure.
Sponsors
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elderly patients (≥65 years old). * Scheduled for elective hip replacement surgery. * ASA (ASA, American Society of Anesthesiologists) physical status I-III. * Able to provide informed consent.
Exclusion criteria
* Known hypersensitivity to remimazolam, flumazenil, or propofol. * Severe hepatic or renal impairment. * History of benzodiazepine or alcohol abuse. * Cognitive impairment that may interfere with the ability to provide consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Emergence | Within one day of surgery | Defined as the time from discontinuation of the anesthetic agent to the time the patient opens their eyes on verbal command. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic Parameters | During operation | Blood pressure measured at various time points including diastolic and systolic blood pressure. |
| Post-Operative Recovery | Within one day of surgery | Assessed using the Modified Aldrete Score.The modified Aldrete score is measured by evaluating five criteria, including the individual's activity level, respiration, circulation, consciousness, and oxygen saturation. A score of 0, 1, or 2 is given for each category, two representing the ideal condition.Given the five parameters, individuals can have a total score from zero to ten. A score lower than nine typically means the individual's status is suboptimal. |
| Adverse Events | Within one day of surgery | Incidence and severity of adverse events related to anesthesia(injection pain, post-induction hypotension, bradycardia and body movement, postoperative nausea and vomiting, intraoperative awareness and delirium, sedation rescue and re-sedation). |
Countries
China
Outcome results
None listed