NCT04149626

Dexmedetomidine Sedation in Orthopedic Surgery

Prospective, Randomized Comparative Study of Intravenous Dexmedetomidine for Sedation in Orthopedic Surgery Under Regional Anesthesia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Asklepieion Voulas General Hospital · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

60 patients ASA I-III, undergoing orthopedic surgery will be randomly assigned into one of three groups, namely group A (n=20), where dexmedetomidine will be used for sedation (initial bolus dose followed by continuous infusion), group B (n=20) where midazolam will be used for sedation (initial bolus dose followed by continuous infusion) and group C (n=20), where remifentanil will be used for sedation (initial bolus dose followed by continuous infusion). All patients will receive spinal anesthesia. Duration of postoperative analgesia, total dose of patient controlled IV morphine, sedation scores, nausea and vomiting, time of ambulation, sleep quality and patient satisfaction will be recorded for the first postoperative day. Additionally chronic pain on the site of surgery will be recorded in 3 and 6 months postoperatively.

Conditions

• Hallux Valgus and Bunion
• Sedation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Sedation using dexmedetomidine (initial bolus dose followed by continuous infusion)
DRUG	Midazolam	Sedation using midazolam (initial bolus dose followed by continuous infusion)
DRUG	Remifentanil	Sedation using remifentanil (initial bolus dose followed by continuous infusion)

Timeline

• Start date: 2020-01-29
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2019-11-04
• Last updated: 2020-01-30

Locations

1 site across 1 country: Greece