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Prospective Study of Remimazolam Besylate Combined with Alfentanil in Gastrointestinal Endoscopy Under Sedation

Prospective Study of Remimazolam Besylate Combined with Alfentanil in Gastrointestinal Endoscopy Under Sedation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043964
Enrollment
Unknown
Registered
2021-03-06
Start date
2021-03-06
Completion date
Unknown
Last updated
2021-07-12

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

Conditions

Digestive Tract Disease

Interventions

Propofol Combined with Alfentanil Group:Propofol 1.5mg/kg
Remimazolam Besylate Combined with Fentanyl Group I:Remimazolam Besylate 0.05mg/kg
Remimazolam Besylate Combined with Fentanyl Group II:Remimazolam Besylate 0.1mg/kg
Remimazolam Besylate Combined with Fentanyl Group III:Remimazolam Besylate 0.15mg/kg

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria were as follows: 1) Aged 18 - 65 years; 2) Patients undergoing painless digestive endoscopy; 3) ASA grade I or II; 4) 18kg/m2 <= BMI <= 28kg/m2; Before the trial, the nature, significance, possible benefits, possible inconvenience and potential danger of the trial should be understood in detail, and the research procedure should be understood and the informed consent should be signed voluntarily.

Exclusion criteria

Exclusion criteria: 1) If the operation time is more than or equal to 30 minutes or endoscopic treatment is needed after digestive endoscopy (such as cholangiopancreatography, endoscopic mucosal resection, endoscopic submucosal dissection, endoscopic ultrasonography, etc.); 2) Patients with sleep apnea; 3) Patients with difficult airway (modified Mahalanobis grade IV); 4) Patients with a history of upper respiratory tract infection in the last two weeks; 5) Anemia or thrombocytopenia, Hb = 2.5xuln, TBIL >= 1.5xuln, albumin ULN; 8) Hypertension patients whose blood pressure was not controlled satisfactorily by antihypertensive drugs (sitting systolic blood pressure >= 180 mmHg, diastolic blood pressure >= 100 mmHg); 9) Allergic or contraindicated to benzodiazepines, opioids, propofol and its components; 10) The patients who could not obtain informed consent or the researchers thought it was not suitable to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Integrated Pulmonary Index;Incidence of Intraoperative Respiratory Depression;Improved Anesthesia Recovery Time;Improved Anesthesia Recovery Time;

Secondary

MeasureTime frame
Onset Time;Hemodynamic variability;Repeated Administration Rate;Patient Satisfaction;

Countries

China

Contacts

Public ContactYunqi Lyu

The First Affiliated Hospital of Zhengzhou University

lyq260703@163.com+86 13939019005

Outcome results

None listed

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