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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam group | Experimental | Patients will receive remimazolam for induction and maintenance of anesthesia. |
|
| Remimazolam + Flumazenil group | Experimental | Patients will receive remimazolam for induction and maintenance, followed by flumazenil to reverse its effects. |
|
| Propofol group | Experimental | Patients will receive propofol for induction and maintenance of anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Emergence | Defined as the time from discontinuation of the anesthetic agent to the time the patient opens their eyes on verbal command. | Within one day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic Parameters | Blood pressure measured at various time points including diastolic and systolic blood pressure. | During operation |
| Hemodynamic Parameters | Heart rate measured at various time points. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ru-Ping MD Dai, PhD | Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, The Second Xiangya Hospital | Changsha | Hunan | 410011 | China | ||
| The Second Xiangya Hospital |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D005442 | Flumazenil |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Flumazenil | Drug | 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. |
|
| Propofol | Drug | 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. |
|
| During operation |
| Post-Operative Recovery | 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. | Within one day of surgery |
| Adverse Events | 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). | Within one day of surgery |
| Changsha |
| Hunan |
| 410011 |
| China |
| D007869 |
| Leg Injuries |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |