Clinical trial NCT06180876: Effect of Remimazolam on Postoperative Delirium
Official title: Effect of General Anesthesia With Remimazolam Versus Propofol on Postoperative Delirium in Elderly Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: General Anesthetic Drug Adverse Reaction
Keywords: general anesthesia
elderly patients
remimazolam
propofol
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 190
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥65 years
* patients scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* American Society of Anesthesiologists status ≥Ⅳ
* history of neurologic or psychiatric diseases
* difficulty in communication
* abuse of drug or alcohol
* suspected allergy to propofol or benzodiazepines

Primary outcomes:
measure: incidence of delirium by 3 days after surgery
timeFrame: from end of surgery to 3 days after surgery, in a total of 3 days
Secondary outcomes:
measure: incidence of delirium by 30 minutes after extubation
timeFrame: from extubation of tracheal tube to 30 minutes after extubation, in a total of 30 minutes
measure: incidence of delirium by 1 day after surgery
timeFrame: from end of surgery to 1 day after surgery, in a total of 1 day
measure: incidence of in-hospital delirium after surgery
timeFrame: from end of surgery to discharge from hospital, in an average of 5 days
measure: time to awake
timeFrame: from end of surgery to response to verbal command, in an average of 10 minutes
measure: incidence of hypotension during surgery
timeFrame: from start of anesthesia induction to extubation, in an average of 2 hours
measure: incidence of hypertension during surgery
timeFrame: from start of anesthesia induction to extubation, in an average of 2 hours
measure: level of tumor necrosis factor α at the end of the surgery
timeFrame: at the end of the surgery
measure: level of serum S100β at the end of the surgery
timeFrame: at the end of the surgery
measure: level of interleukin α at the end of the surgery
timeFrame: at the end of the surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital, Fourth military medical university
state: Shaanxi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.