Effect on Early Cognition Under Sedation by Rimazole Toluenesulfonate in Old Patient Undergoing Colonoscopy

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

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-02

Study Completion Date

2024-12-30

Brief Summary

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To investigate the effect on cognition under sedation by Rimazole toluenesulfonatein elderly patients undergoing colonoscopy

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Detailed Description

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Conditions

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Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Remimazolam

IV Remimazolam tosilate 0.3mg/kg

Group Type EXPERIMENTAL

Remimazolam tosilate

Intervention Type DRUG

IV before procedure

propofol

IV propofol 1.2\~2.5mg/kg

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

IV before procedure

saline

IV saline solution 10ml

Group Type PLACEBO_COMPARATOR

saline solution

Intervention Type OTHER

IV before procedure

Interventions

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Remimazolam tosilate

IV before procedure

Intervention Type DRUG

Propofol

IV before procedure

Intervention Type DRUG

saline solution

IV before procedure

Intervention Type OTHER

Other Intervention Names

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experimental active comparator placebo comparator

Eligibility Criteria

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Inclusion Criteria

1. ASA I\~II
2. patients will be treatmented by sedation under colonoscopy
3. sign informed consent

Exclusion Criteria

(1) Preoperative depression and cognitive impairment

（2） Hearing or visual impairment;

（3） Drug abuse, alcoholism or long-term use of antidepressants;

（4） Cardiovascular and cerebrovascular accidents, neurological sequelae, or severe liver and kidney function damage occurred within 6 months

（5） BMI \< 18, BMI \> 30

（6） Confirmed or suspected allergy to the test drug

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No