Propofol for Prophylaxis of Morphine Induced Pruritis in Caesarean Section

NCT ID: NCT06188546

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-03-01

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.

Conditions

Pruritus Caused by Drug

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group 0

Will receive no drugs for pruritis prophylaxis

Group Type: PLACEBO_COMPARATOR

Propofol

Intervention Type: DRUG

trying different dosages of propofol 10mg/ml IV to determine the prophylactic dose for morphine induced pruritis

Group 1

Will receive 1ml of propofol 10 mg/ml

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

trying different dosages of propofol 10mg/ml IV to determine the prophylactic dose for morphine induced pruritis

Group 2

Will receive 2 ml of propofol 10mg/ml

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

trying different dosages of propofol 10mg/ml IV to determine the prophylactic dose for morphine induced pruritis

Group 3

Will receive 3 ml of propofol 10mg/ml

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

trying different dosages of propofol 10mg/ml IV to determine the prophylactic dose for morphine induced pruritis

Interventions

Propofol

trying different dosages of propofol 10mg/ml IV to determine the prophylactic dose for morphine induced pruritis

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sohila Khaled Mohamed Hassan

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zein Zarea, MD

Role: STUDY_CHAIR

Assiut University

Diab Fuad Hetta, MD

Role: STUDY_DIRECTOR

South Egypt's cancer institute

Rania Mohamed Abdelemam, MD

Role: STUDY_DIRECTOR

South Egypt's cancer institute

Central Contacts

Sohila K Hassan, MBBCH

Role: CONTACT

khaledsohila@gmail.com

201010328326

Other Identifiers

propofol for pruritis

Identifier Type: -

Identifier Source: org_study_id