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Effects of Remazolam Toluene Sulfonate for Injection on Ventilation and Oxygenation in Patients Undergoing Colonoscopy: a Multicenter, Randomized, Single Blind, Positive Drug Parallel Controlled Clinical Trial

Effects of Remazolam Toluene Sulfonate for Injection on Ventilation and Oxygenation in Patients Undergoing Colonoscopy: a Multicenter, Randomized, Single Blind, Positive Drug Parallel Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034527
Enrollment
Unknown
Registered
2020-07-08
Start date
2020-08-01
Completion date
Unknown
Last updated
2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painless colonoscopy

Interventions

experimental group:Induction and maintenance of anesthesia with remazolam tosylate
control group:Propofol for induction and maintenance anesthesia

Sponsors

Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18- 60 years, gender is not limited; 2) General anesthesia patients receiving routine colonoscopy diagnosis and treatment; 3) ASA score is grade I or II; 4) 18kg/m2 < BMI < 30kg/m2.

Exclusion criteria

Exclusion criteria: 1) Patients to be intubated; 2) Patients with difficult airway; 3) Anemia or thrombocytopenia, HB = 2.5 * ULN, TBIL >= 1.5 * ULN; 5) Renal function is abnormal, and serum creatinine is greater than the normal upper limit; 6) Hypertensive patients whose blood pressure is not satisfactorily controlled by antihypertensive drugs (systolic pressure >= 160mmHg and/or diastolic pressure >= 100 mmHg); 7) Systolic blood pressure <= 90 mmHg; 8) Pregnant or breast-conserving women; 9) Patients allergic to benzodiazepines and opioids; 10) Attended clinical trials of other drugs as subjects in the past 3 months; 11) The researcher thinks that it is inappropriate for patients to participate in this test or the patients themselves refuse to do so.

Design outcomes

Secondary

MeasureTime frame
Number of airway interventions;Indicators of ventilation and oxygenation;Hemodynamic index;Efficacy index;Calm Allen Su Time;Incidence of adverse reactions;

Primary

MeasureTime frame
Time from completion of anesthesia induction administration to first airway intervention;

Countries

China

Contacts

Public ContactBai YiPing

Affiliated Hospital of Southwest Medical University

baiyiping0608@163.com+86 136 4904 9901

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026