drugset / Trial / NCT04673812
Influence Of Low Dose Intrathecal Naloxone On Bupivacaine - Fentanyl Spinal Anaesthesia For Lower Limb Orthopedic Surgery In Elderly Patients
RandomizedParallel-groupTriple-blindPrevention
Summary
Fentanyl is a safer alternative than morphine in the management of postoperative pain in elderly. However, pruritus, nausea and vomiting are unwanted side effects of intrathecal fentanyl administration, that can decrease patient satisfaction with anaesthesia, delay post anaesthesia care unit ( PACU ) discharge, and increase costs. The incidence of pruritus with neuraxial fentanyl is high. The incidence of pruritus in non-obstetric surgery patients after intrathecal fentanyl ranges from 53% to 79%. Naloxone hydrochloride is a pure opioid competitive antagonist. Small doses of naloxone may reduce Fentanyl-associated adverse effects, such as pruritus, nausea and vomiting without affecting analgesia.
Timeline
- Start
- 2020-12-10
- Primary completion
- 2021-03-10
- Completion
- 2021-03-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Naloxone | Small molecule | 20 ug | Intrathecal |
| Comparator | Bupivacaine | Other / unclassified | 12.5 mg | Intrathecal |
| Comparator | Fentanyl | Other / unclassified | 25 ug | Intrathecal |
Indications
No indication recorded.