Propofol for Prophylaxis of Morphine Induced Pruritis in Caesarean Section

Phase 3

Not yet recruiting

• Conditions: Pruritus Caused by Drug
• Interventions: Drug: Propofol

• Registration Number: NCT06188546
• Lead Sponsor: Assiut University

Brief Summary

the goal of this randomized clinical trial is to find the optimum sub hypnotic dose of iv propofol that prevents the incidence of itching induced from intrathecal morphine used in spinal anesthesia in caesarean section operation. the main questions it aim to answer are the number of patients complained of pruritus in the first 24 hours post operative period and the severity of the pruritus. participants will be divided into 4 groups. 1st group receives 0 mg of propofol , 2nd receives 10 mg , 3rd receives 20 mg and the 4th receives 30 mg.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study Start: 2024-01-01
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. The study is scheduled for women undergoing elective caesarean section under spinal anesthesia.
2. The subject is ≥ 20 years and ≤ 40 years.
3. No obvious abnormalities in preoperative ECG, blood routine, electrolytes, and other tests.
4. ASA class 1-2.

Exclusion Criteria

• Patients who had a known allergy to propofol, morphine, or bupivacaine.
• Those with preexisting pruritus caused by pregnancy, a coexisting skin disorder, or other pruritogenic systemic diseases.
• Patients with a contraindication to spinal anaesthesia
• Failed block
• Need of extra sedation intra-operative
• Positive history for asthma or COPD.
• Patient refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Propofol	Will receive 2 ml of propofol 10mg/ml
Group 0	Propofol	Will receive no drugs for pruritis prophylaxis
Group 1	Propofol	Will receive 1ml of propofol 10 mg/ml
Group 3	Propofol	Will receive 3 ml of propofol 10mg/ml

Primary Outcome Measures

Name	Time	Method
number of participants complained of pruritus in the first 24hr post operative period	first 24 hours post operative period