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The effect of remazolam and dexmedetomidine on respiratory function during intraoperative sedation

The effect of remazolam and dexmedetomidine on respiratory function during intraoperative sedation: a multi-center randomized controlled trialpatients: a multi-center randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089667
Enrollment
Unknown
Registered
2024-09-12
Start date
2024-10-08
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Diaphragmatic weakness in elderly patients undergoing lower extremity fracture surgery under intraoperative sedation

Interventions

Remazolam sedation group:The initial dose of remazolam group is 0.075 mg/kg and maintained by 0.5mg/kg*h for 5 minutes. When the patient did not reach the MOAA/S score of 3, the infusion rate of remaz
Dexmedetomidine sedation group:A loading dose of 1µg/kg of dexmedetomidine was given and the infusion was completed within 10 minutes. The infusion rate was maintained by titration method with the ini

Sponsors

The First Affiliated Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age =65 years old; 2.ASA physical status I-III; 3.surgical duration <120min; 4.Elective orthopedic surgery of knee joint and below knee joint;

Exclusion criteria

Exclusion criteria: 1.Exclusion criteria:Emergency surgery and/or intraoperative massive bleeding; 2.History of anaesthesia related drug allergy; 3.Severe heart, lung, liver, kidney, nervous, blood system diseases or muscle related diseases; 4.Use drugs known to affect neuromuscular function or cause drowsiness within 2 weeks; 5.Mental illness; 6.Patients enrolled in other clinical trials within 6 months; 7.Anesthesia failure due to puncture failure; 8.Preoperative application of anticoagulants; 9.The patient refused;

Design outcomes

Primary

MeasureTime frame
Diaphragm thickening fraction during tidal breat;

Secondary

MeasureTime frame
Diaphragm thickness during tidal breathing;Diaphragm excursion during tidal breathing;Incidence of diaphragm weakness;Diaphragm thickening fraction during maximal inspiration;Diaphragm thickeness during maximal inspiration;Diaphragm excursion during maximal inspiration;Diaphragm thickness during tidal breathing;

Countries

China

Contacts

Public ContactJiehao Sun

The First Affiliated Hospital, Wenzhou Medical University

sun_jiehao@126.com+86 136 7672 1930

Outcome results

None listed

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