drugset / Trial / NCT04149626

Dexmedetomidine Sedation in Orthopedic Surgery

NCT04149626

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2020-01-29
Primary completion
2021-12
Completion
2022-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified Intravenous
Comparator Midazolam Small molecule
Comparator Remifentanil Small molecule

Indications

No indication recorded.