Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery

NCT06300346 | Not Yet Recruiting

• 1 other identifier: Soh-Med-23-12-02MS
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Conditions

Emetic Attacks During Caesarean Delivery With Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of nausea and vomiting with spinal anesthesia

  To compare between Propofol, Ondansetron and Pregabalin for control of emetic attacks during caesarean delivery with spinal anesthesia.

  5 months

Secondary Outcomes (1)

• Measurement of hemodynamics postoperative

  5 months

Study Arms (3)

propofol

ACTIVE COMPARATOR

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.

Drug: Propofol

pregabalin

ACTIVE COMPARATOR

30 Patients will receive three capsules of pregabalin 100 mg once one hour before the surgical incision.

Drug: Propofol

ondansetron

ACTIVE COMPARATOR

30 Patients will receive 4 mg ondansetron in 10 ml saline intravenously 5 min before spinal puncture.

Drug: Propofol

Interventions

Propofol DRUG

Ondansetron

Also known as: Pregabalin

ondansetron; pregabalin; propofol

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (4)

• 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.

  PMID: 25984542 BACKGROUND

• 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.

  PMID: 35011852 BACKGROUND

• 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.

  PMID: 32346211 BACKGROUND

• 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.

  PMID: 32913634 BACKGROUND

MeSH Terms

Interventions

Propofol; Pregabalin

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Ebtihal A Abd-Ellateef, resident

CONTACT

01119925603; ebtehalahmed@med.sohag.edu.eg

Ahmed M Abd-Elmaboud, assistant professor

CONTACT

01150217744

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at Anesthesiology, Surgical Intensive Care and Pain Medicine department

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 8, 2024
• Study Start: March 1, 2024
• Primary Completion: August 18, 2024
• Study Completion: August 18, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03