Propofol for Prophylaxis of Morphine Induced Pruritis in Caesarean Section

December 19, 2023 updated by: Sohila Khaled Mohamed Hassan, Assiut University

Administration of Propofol for Prophylaxis of Intrathecal Morphine Induced Pruritus in Caesarean Section

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group 0
Will receive no drugs for pruritis prophylaxis
Drug: Propofol
trying different dosages of propofol 10mg/ml IV to determine the prophylactic dose for morphine induced pruritis
Active Comparator: Group 1
Will receive 1ml of propofol 10 mg/ml
Drug: Propofol
trying different dosages of propofol 10mg/ml IV to determine the prophylactic dose for morphine induced pruritis
Active Comparator: Group 2
Will receive 2 ml of propofol 10mg/ml
Drug: Propofol
trying different dosages of propofol 10mg/ml IV to determine the prophylactic dose for morphine induced pruritis
Active Comparator: Group 3
Will receive 3 ml of propofol 10mg/ml
Drug: Propofol
trying different dosages of propofol 10mg/ml IV to determine the prophylactic dose for morphine induced pruritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of participants complained of pruritus in the first 24hr post operative period
Time Frame: first 24 hours post operative period
first 24 hours post operative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Zein Zarea, MD, Assiut University
  • Study Director: Diab Fuad Hetta, MD, South Egypt's cancer institute
  • Study Director: Rania Mohamed Abdelemam, MD, South Egypt's cancer institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Estimated)

January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • propofol for pruritis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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