Effect of Remimazolam on Postoperative Delirium

General Anesthetic Drug Adverse Reaction Clinical Trial

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Official title:

Effect of General Anesthesia With Remimazolam Versus Propofol on Postoperative Delirium in Elderly Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180876
• Other study ID #: XJH-A-20220628
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: December 2023
• Source: Air Force Military Medical University, China
• Contact: Zhihong Lu
• Phone: +8613891975018
• Email: deerlu23[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: January 30, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age =65 years

• patients scheduled for elective surgery under general anesthesia

Exclusion Criteria:

• American Society of Anesthesiologists status =?

• history of neurologic or psychiatric diseases

• difficulty in communication

• abuse of drug or alcohol

• suspected allergy to propofol or benzodiazepines

Related Conditions & MeSH terms

• Delirium
• Drug-Related Side Effects and Adverse Reactions
• Emergence Delirium
• General Anesthetic Drug Adverse Reaction

Intervention

Drug:
• remimazolam
continuous infusion
• propofol
continuous infusion

Locations

Country	Name	City	State
China	Xijing hospital, Fourth military medical university	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Zhihong LU

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of delirium by 3 days after surgery		from end of surgery to 3 days after surgery, in a total of 3 days
Secondary	incidence of delirium by 30 minutes after extubation		from extubation of tracheal tube to 30 minutes after extubation, in a total of 30 minutes
Secondary	incidence of delirium by 1 day after surgery		from end of surgery to 1 day after surgery, in a total of 1 day
Secondary	incidence of in-hospital delirium after surgery		from end of surgery to discharge from hospital, in an average of 5 days
Secondary	time to awake		from end of surgery to response to verbal command, in an average of 10 minutes
Secondary	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
Secondary	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
Secondary	level of tumor necrosis factor a at the end of the surgery		at the end of the surgery
Secondary	level of serum S100ß at the end of the surgery		at the end of the surgery
Secondary	level of interleukin a at the end of the surgery		at the end of the surgery