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Effect of Remimazolam on Postoperative Delirium

NCT ID: NCT06180876

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2024-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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General Anesthetic Drug Adverse Reaction

Keywords

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general anesthesia elderly patients remimazolam propofol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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remimazolam

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

Group Type EXPERIMENTAL

remimazolam

Intervention Type DRUG

continuous infusion

propofol

propofol continuous infusion is used for general anesthesia; dosage:4-8mg/kg/h; duration: from start of anesthesia induction to end of surgery

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

continuous infusion

Interventions

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remimazolam

continuous infusion

Intervention Type DRUG

propofol

continuous infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhihong LU

OTHER

Sponsor Role lead

Responsible Party

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Zhihong LU

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Xijing hospital, Fourth military medical university

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhihong Lu

Role: CONTACT

Phone: +8613891975018

Email: [email protected]

Facility Contacts

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Zhihong Lu

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 35004991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34390228 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34354587 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32417976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34092775 (View on PubMed)

Other Identifiers

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XJH-A-20220628

Identifier Type: -

Identifier Source: org_study_id