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Remimazolam is a novel benzodiazepine with ultra-short onset and offset of its effect. It can be used for general anesthesia. However, classical benzodiazepine such as midazolam was reported to increase the risk of postoperative delirium. Thus, the investigators aim to investigate the effect of remimazolam general anesthesia on postoperative delirium in elderly patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remimazolam | Experimental | remimazolam continuous infusion is used for general anesthesia; dosage:0.7-1.5mg/kg/h; duration: from start of anesthesia induction to end of surgery |
|
| propofol | Active Comparator | propofol continuous infusion is used for general anesthesia; dosage:4-8mg/kg/h; duration: from start of anesthesia induction to end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remimazolam | Drug | continuous infusion |
| |
| propofol |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of delirium by 3 days after surgery | from end of surgery to 3 days after surgery, in a total of 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of delirium by 30 minutes after extubation | from extubation of tracheal tube to 30 minutes after extubation, in a total of 30 minutes | |
| incidence of delirium by 1 day after surgery | from end of surgery to 1 day after surgery, in a total of 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing hospital, Fourth military medical university | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35004991 | Background | Tang F, Yi JM, Gong HY, Lu ZY, Chen J, Fang B, Chen C, Liu ZY. Remimazolam benzenesulfonate anesthesia effectiveness in cardiac surgery patients under general anesthesia. World J Clin Cases. 2021 Dec 6;9(34):10595-10603. doi: 10.12998/wjcc.v9.i34.10595. | |
| 34390228 | Background | Liu T, Lai T, Chen J, Lu Y, He F, Chen Y, Xie Y. Effect of remimazolam induction on hemodynamics in patients undergoing valve replacement surgery: A randomized, double-blind, controlled trial. Pharmacol Res Perspect. 2021 Oct;9(5):e00851. doi: 10.1002/prp2.851. |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
continuous infusion |
|
| time to awake | from end of surgery to response to verbal command, in an average of 10 minutes |
| incidence of hypotension during surgery | hypotension is defined as systolic blood pressure decreasing by more than 20% of baseline value | from start of anesthesia induction to extubation, in an average of 2 hours |
| incidence of hypertension during surgery | hypertension is defined as systolic blood pressure increasing by more than 20% of baseline value | from start of anesthesia induction to extubation, in an average of 2 hours |
| Duration of sleep on the first night after surgery | sleep is monitored by a wrist acti-graphy | from end of surgery to 24 hours after surgery, in a total of 24 hours |
| 34354587 | Background | Kilpatrick GJ. Remimazolam: Non-Clinical and Clinical Profile of a New Sedative/Anesthetic Agent. Front Pharmacol. 2021 Jul 20;12:690875. doi: 10.3389/fphar.2021.690875. eCollection 2021. |
| 32417976 | Background | Doi M, Morita K, Takeda J, Sakamoto A, Yamakage M, Suzuki T. Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial. J Anesth. 2020 Aug;34(4):543-553. doi: 10.1007/s00540-020-02788-6. Epub 2020 May 16. |
| 34092775 | Background | Oka S, Satomi H, Sekino R, Taguchi K, Kajiwara M, Oi Y, Kobayashi R. Sedation outcomes for remimazolam, a new benzodiazepine. J Oral Sci. 2021 Jun 29;63(3):209-211. doi: 10.2334/josnusd.21-0051. Epub 2021 Jun 7. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |