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Investigation of the Effect of Ondansetron on Preventing Hypotention Following Spinal Anesthesia

Investigation of the Effect of Intravenous Injection of Ondansetron on Preventing Hypotention Following Spinal Anesthesia in Caesarean Section

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241024063488N2
Enrollment
70
Registered
2025-03-03
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension following caesarean section. Hypotension

Interventions

Intervention 1: Intervention group: Patients in the intervention group will receive 4 mg of ondansetron, manufactured by Tehran Chemie Company, in 8 cc of normal saline, manufactured by Samen Pharmace

Sponsors

Birjand University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Informed consent to enter the study ASA class 1 and 2 Term pregnancy, singleton pregnancy, and elective caesarean section Availability of desired information

Exclusion criteria

Exclusion criteria: Patients with brain trauma, febrile illness, spine problems, spinal anesthesia site infection, blood coagulation disorders, heart valve problems, especially aortic valve stenosis, and any chronic cardiovascular, kidney, and neuropsychiatric diseases. Suffering from preeclampsia or any type of hypertension during pregnancy Patients with high ICP or hypovolemic patients Drug addiction Allergy to local anesthetics or ondansetron Inability to position properly People with long QTc on ECG People with severe constipation People with headaches in the past People taking SSRI drugs in the past

Design outcomes

Primary

MeasureTime frame
Systolic Blood pressure. Timepoint: Every two minutes after intervention until the baby is discharged and after that every 5 minutes until the mother is discharged from recovery. Method of measurement: Sa'adat Monitoring Device.;Diastolic Blood pressure. Timepoint: Every two minutes after intervention until the baby is discharged and after that every 5 minutes until the mother is discharged from recovery. Method of measurement: Sa'adat Monitoring Device.;Mean Arterial Pressure (MAP). Timepoint: Every two minutes after intervention until the baby is discharged and after that every 5 minutes until the mother is discharged from recovery. Method of measurement: Sa'adat Monitoring Device.;Heart Rate. Timepoint: Every two minutes after intervention until the baby is discharged and after that every 5 minutes until the mother is discharged from recovery. Method of measurement: Sa'adat Monitoring Device.;Arterial oxygen saturation. Timepoint: Every two minutes after intervention until the baby is discharged and after that every 5 minutes until the mother is discharged from recovery. Method of measurement: Sa'adat Monitoring Device.;Frequency of postoperative nausea and vomiting. Timepoint: From the start of the intervention until three hours after the end of the intervention. Method of measurement: History and clinical examination.;Frequency of chills after surgery. Timepoint: From the start of the intervention until three hours after the end of the intervention. Method of measurement: History and clinical examination.;Cumulative dose of ephedrine. Timepoint: From the start of the intervention until three hours after the end of the intervention. Method of measurement: Researcher-made checklist.;Cumulative dose of atropine drugs. Timepoint: From the start of the intervention until three hours after the end of the intervention. Method of measurement: Researcher-made checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Fanoodi

Birjand University of Medical Sciences

Fanoodi.af@gmail.com+98 56 3203 1048

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026