Clinical trial NCT06300346: Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery
Official title: Comparison Between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks During Caesarean Delivery With Spinal Anesthesia: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emetic Attacks During Caesarean Delivery With Spinal Anesthesia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 90
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of nausea and vomiting with spinal anesthesia
timeFrame: 5 months
Secondary outcomes:
measure: Measurement of hemodynamics postoperative
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
References:
citation: Hirmanpour A, Safavi M, Honarmand A, Hosseini AZ, Sepehrian M. The comparative study of intravenous Ondansetron and sub-hypnotic Propofol dose in control and treatment of intrathecal Sufentanil-induced pruritus in elective caesarean surgery. J Res Pharm Pract. 2015 Apr-Jun;4(2):57-63. doi: 10.4103/2279-042X.155751.
citation: Mokini Z, Genocchio V, Forget P, Petrini F. Metoclopramide and Propofol to Prevent Nausea and Vomiting during Cesarean Section under Spinal Anesthesia: A Randomized, Placebo-Controlled, Double-Blind Trial. J Clin Med. 2021 Dec 26;11(1):110. doi: 10.3390/jcm11010110.
citation: Athavale A, Athavale T, Roberts DM. Antiemetic drugs: what to prescribe and when. Aust Prescr. 2020 Apr;43(2):49-56. doi: 10.18773/austprescr.2020.011. Epub 2020 Apr 1.
citation: Elvir-Lazo OL, White PF, Yumul R, Cruz Eng H. Management strategies for the treatment and prevention of postoperative/postdischarge nausea and vomiting: an updated review. F1000Res. 2020 Aug 13;9:F1000 Faculty Rev-983. doi: 10.12688/f1000research.21832.1. eCollection 2020.