drugset / Trial / NCT04518618

Effect of Intrathecal Naloxone in the Incidence of Pruritis After C.S

NCT04518618

Completed 96 enrolled Tanta University
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

This randomized prospective double-blind trial will be conducted on 80 Full-term pregnant females aged 21- 30 years presented for elective cesarean section under spinal anesthesia where they will be randomly allocated into two equal groups:- * Group F (40 Patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml). * Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ug naloxone. The study aim is to evaluate the effect of adding an ultra-low dose of naloxone (20 ug) to hyperbaric bupivacaine (10 mg0 and fentanyl (25 ug) in spinal anesthesia for C.S. Primary outcome: The incidence of pruritis Secondary outcome: The onset, the duration, the site, and the severity of pruritis.

Timeline

Start
2020-09-11
Primary completion
2021-03-07
Completion
2021-03-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxone Small molecule 20 ug Intrathecal
Background Fentanyl Other / unclassified 25 ug Intrathecal

Indications

No indication recorded.