Administration of Propofol for Prophylaxis of Intrathecal Morphine Induced Pruritus in Caesarean Section
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 200
- Primary Endpoint
- number of participants complained of pruritus in the first 24hr post operative period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
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
Arms & Interventions
Group 0
Will receive no drugs for pruritis prophylaxis
Intervention: Propofol (Drug)
Group 1
Will receive 1ml of propofol 10 mg/ml
Intervention: Propofol (Drug)
Group 2
Will receive 2 ml of propofol 10mg/ml
Intervention: Propofol (Drug)
Group 3
Will receive 3 ml of propofol 10mg/ml
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
number of participants complained of pruritus in the first 24hr post operative period
Time Frame: first 24 hours post operative period
Secondary Outcomes
No secondary outcomes reported
Investigators
Sohila Khaled Mohamed Hassan
doctor
Assiut University