Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery

Not Applicable

Not yet recruiting

• Conditions: Emetic Attacks During Caesarean Delivery With Spinal Anesthesia
• Interventions: Drug: Propofol

• Registration Number: NCT06300346
• Lead Sponsor: Sohag University

Brief Summary

Single shot spinal anesthesia is widely used for most surgical operations especially in obstetric such as hysterectomy, tubal ligation after vaginal delivery, cesarean and curettage etc.; however, in general, cesarean is considered as the most common indication for spinal anesthesia in pregnant women Intra-operative nausea and vomiting/retching (NVR) may be experienced by 20% to 80% of women undergoing cesarean section (CS) with subarachnoid anesthesia (SA) in the absence of antiemetic prophylaxis.

Different treatment options are available to reduce post operative nausea and vomiting (PONV) so we will make a Comparison between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks during Caesarean Delivery with Spinal Anesthesia

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-14
• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted QC: 2024-03-03
• Last Update Submitted: 2024-03-03
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-08-18
• Study Completion: 2024-08-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Age: 21-40 years old.
• Physical status American Society of Anesthesiologists (ASA)I&II.
• Body mass index (BMI) < 35&>20 kg/m2.
• Elective uncomplicated cesarean section under spinal anesthesia.

Exclusion Criteria

• Patient refusal.
• Patients with known history of allergy to study drugs.
• Advanced hepatic, renal and respiratory diseases.
• Psychological and mental disorders.
• Patient with reduced level of consciousness.
• Hypertensive, cardiac, and diabetic patients.
• Patients receiving anticoagulants therapy or suspected coagulopathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol	Propofol	30 Patients will receive propofol as equal volumes of both 1% of propofol 10mg/ml and0.9% normal saline will be drawn in a 20-ml syringe before spinal puncture.
pregabalin	Propofol	30 Patients will receive three capsules of pregabalin 100 mg once one hour before the surgical incision.
ondansetron	Propofol	30 Patients will receive 4 mg ondansetron in 10 ml saline intravenously 5 min before spinal puncture.

Primary Outcome Measures

Name	Time	Method
Incidence of nausea and vomiting with spinal anesthesia	5 months	To compare between Propofol, Ondansetron and Pregabalin for control of emetic attacks during caesarean delivery with spinal anesthesia.

Secondary Outcome Measures

Name	Time	Method
Measurement of hemodynamics postoperative	5 months	Measurement of hemodynamics postoperative and Incidence of other side effects as :hypotension measured by non invasive blood pressure monitoring