NCT06715657

Effect of Propofol Administration Time on the Incidence and Severity of Intrathecal Morphine-induced Pruritus in Parturient Undergoing Elective Cesarean Delivaries

Effect of Propofol Administration Time on the Incidence and Severity of Intrathecal Morphine-induced Pruritus in Parturient Undergoing Elective Cesarean Delivaries: A Prospective, Randomized, Comparative Controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Our hypothesis suggests that Administration time of intravenous propofol may affect Pruritus incidence and severity that occur after intrathecal morphine in parturient undergoing elective cesarean section (CS). the aim of the study is to investigate effect of prophylactic administration of intravenous sub-hypnotic dose of propofol before intrathecal morphine compared with the administration after intrathecal morphine on intrathecal morphine-induced pruritus incidence and severity in parturient undergoing elective cesarean delivaries.

Detailed description

Neuraxial Anaesthesia is a frequent anaesthetic approach for cesarean delivery and other lower abdominal and lower limb anaesthetic procedures. Neuraxial morphine addition to local anaesthetic provides an effective and prolonged postoperative analgesia, but has been associated with a frequent incidence of pruritus and postoperative nausea and vomiting (PONV). Neuraxial opioids are thought to act on central nervous system pathways to cause pruritus. Although precise mechanisms are incompletely understood, Numerous interventions have been investigated to prevent opioid-induced pruritus in the peripartum period as: Opioid receptor agonist-antagonists, Serotonin receptor antagonists. There is dense concentration of opioid receptors and 5-HT3 receptors in the dorsal part of the spinal cord and nucleus of the spinal tract of the trigeminal nerve in the medulla. Activation of these receptors by neuraxial opioid administration or by circulating estrogen in parturient results in pruritus which is usually localized to face, neck, or upper thorax. Propofol exerts its antipruritic action through inhibition of the posterior horn transmission in spinal cord. Series of clinical trials have reported that a sub-hypnotic dose of propofol is equally effective in reducing the incidence of pruritus following intrathecal morphine. however these studies have limited information about dose and timing of administration of propofol.

Conditions

• Cesarean Section

Interventions

Type	Name	Description
DRUG	Morphine intrathecal	patients intrathecal anaesthesia with morphine
DRUG	propofol	patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection 15 min before the end of surgery
DRUG	propofol	patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2024-12-04
• Last updated: 2024-12-04

Regulatory

• FDA-regulated drug study