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Safety and efficacy of remimazolam tosilate combined with low-dose fentanyl for procedural sedation in obese patients undergoing gastroscopy

Safety and efficacy of remimazolam tosilate combined with low-dose fentanyl for procedural sedation in obese patients undergoing gastroscopy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067076
Enrollment
Unknown
Registered
2022-12-26
Start date
2023-11-06
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

gastroscopy

Interventions

Intervention group:Remimazolam tosilate and fentanyl
Control group:Propofol and fentanyl

Sponsors

The First Affiliated Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. BMI 30~39.9 kg/m2; 2. Aged 18~50 years old; 3. ASA class ?.

Exclusion criteria

Exclusion criteria: 1. Patients with known contraindications to any of the drugs in this study; 2. Patients requiring gastroscopic treatment; 3. Patients with a full stomach; 4. Pregnant women; 5. Patients classified as ASA Class ? or higher; 6. Patients with a history of sedative or opioid use in the past 6 months; 7. Patients with mental disorders; 8. Patients with anemia (hemoglobin <= 90 g/L); 9. Patients with preoperative AIS scores higher than 6.

Design outcomes

Primary

MeasureTime frame
The incidence of hypoxemia;

Secondary

MeasureTime frame
The time to ambulation;Need for airway maneuvers;Need for remedial sedation;Sleep quality;The incidence of sedation failure;The cost of sedatives;

Countries

China

Contacts

Public ContactLijuan Yan

The First Affiliated Hospital of Xiamen University

yanlijuan0122@126.com+86 157 1066 8779

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026