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Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery

S

Sohag University

Status

Not yet enrolling

Conditions

Emetic Attacks During Caesarean Delivery With Spinal Anesthesia

Treatments

Drug: Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT06300346
Soh-Med-23-12-02MS

Details and patient eligibility

About

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

Enrollment

90 estimated patients

Sex

Female

Ages

21 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

propofol
Active Comparator group
Description:
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.
Treatment:
Drug: Propofol
pregabalin
Active Comparator group
Description:
30 Patients will receive three capsules of pregabalin 100 mg once one hour before the surgical incision.
Treatment:
Drug: Propofol
ondansetron
Active Comparator group
Description:
30 Patients will receive 4 mg ondansetron in 10 ml saline intravenously 5 min before spinal puncture.
Treatment:
Drug: Propofol

Trial contacts and locations

0

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Central trial contact

Ebtihal A Abd-Ellateef, resident; Ahmed M Abd-Elmaboud, assistant professor

Data sourced from clinicaltrials.gov

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