Propofol for Prophylaxis of Morphine Induced Pruritis in Caesarean Section

Assiut University

Status and phase: Not yet enrolling; Phase 3

Conditions: Pruritus Caused by Drug

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06188546

propofol for pruritis

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

200 participants in 4 patient groups, including a placebo group

Group 0

Placebo Comparator group

Description:

Will receive no drugs for pruritis prophylaxis

Treatment:

Drug: Propofol

Group 1

Active Comparator group

Description:

Will receive 1ml of propofol 10 mg/ml

Treatment:

Drug: Propofol

Group 2

Active Comparator group

Description:

Will receive 2 ml of propofol 10mg/ml

Treatment:

Drug: Propofol

Group 3

Active Comparator group

Description:

Will receive 3 ml of propofol 10mg/ml

Treatment:

Drug: Propofol