Propofol for Prophylaxis of Morphine Induced Pruritis in Caesarean Section

NCT06188546 | Unknown Phase 3 FDA Drug

• 1 other identifier: propofol for pruritis
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Keywords

morphine induced pruritus

Outcome Measures

Primary Outcomes (1)

• number of participants complained of pruritus in the first 24hr post operative period

  first 24 hours post operative period

Study Arms (4)

Group 0

PLACEBO COMPARATOR

Will receive no drugs for pruritis prophylaxis

Drug: Propofol

Group 1

ACTIVE COMPARATOR

Will receive 1ml of propofol 10 mg/ml

Drug: Propofol

Group 2

ACTIVE COMPARATOR

Will receive 2 ml of propofol 10mg/ml

Drug: Propofol

Group 3

ACTIVE COMPARATOR

Will receive 3 ml of propofol 10mg/ml

Drug: Propofol

Interventions

Propofol DRUG

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

Group 0; Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Zein Zarea, MD

  Assiut University

  STUDY CHAIR

• Diab Fuad Hetta, MD

  South Egypt's cancer institute

  STUDY DIRECTOR

• Rania Mohamed Abdelemam, MD

  South Egypt's cancer institute

  STUDY DIRECTOR

Central Study Contacts

Sohila K Hassan, MBBCH

CONTACT

201010328326; khaledsohila@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 3, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share