NCT05567523

Safety Study of Dexmedetomidine in Elderly Under General Anesthesia

Effects of Dexmedetomidine at Different Doses on Hemodynamics and Recovery Quality in Elderly Patients Undergoing Hip Replacement Surgery Under General Anesthesia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Zhenjiang First People's Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out appropriate dose range of dexmedetomidine to provide the elderly patients satisfactory sedation and analgesia with stable hemodynamics during perioperative period of hip replacement under general anesthesia.

Detailed description

All patients will be screened to determine eligibility for study entry, and the patients who meet the eligibility requirements will be informed about the study and potential risks. After giving written informed consent, the patients will be randomized into different doses of dexmedetomidine groups and the comparative groups in a same ratio.

Conditions

• Hip Fractures
• Hip Disease

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	In dexmedetomidine groups, patients will be pumped 0.1ml/kg of dexmedetomidine (contained dexmedetomidine 0.25/0.5/0.75µg/kg in Group D0.25/D0.5/D0.75) for 15min before anesthesia induction, following continuous infusion at the rate of 0.125ml/kg/h until the end of operation.
DRUG	Normal saline	normal saline
DRUG	Midazolam	midazolam

Timeline

• Start date: 2019-06-01
• Primary completion: 2022-02-28
• Completion: 2022-03-30
• First posted: 2022-10-05
• Last updated: 2022-10-13

Locations

1 site across 1 country: China