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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 4

Conditions: Cognition

Treatments: Other: saline solution; Drug: Remimazolam tosilate; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05255211

WanYi（2020-5）

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 3 patient groups, including a placebo group

Remimazolam

Experimental group

Description:

IV Remimazolam tosilate 0.3mg/kg

Treatment:

Drug: Remimazolam tosilate

propofol

Active Comparator group

Description:

IV propofol 1.2\~2.5mg/kg

Treatment:

Drug: Propofol

saline

Placebo Comparator group

Description:

IV saline solution 10ml

Treatment:

Other: saline solution