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Granisetron Use, Blood Pressure, and Nausea and Vomiting During Cesarean Delivery Under Spinal Anesthesia

ConditionsHypotensionNauseaVomitingCesarean Section
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorKayseri City Hospital

About this trial

This study will observe 80 adults having a cesarean delivery under spinal anesthesia at Kayseri City Hospital. It will compare patients who receive granisetron as part of routine care to prevent nausea and vomiting with patients who do not receive preventive anti-nausea medicine. Granisetron use is decided by the treating anesthesiologist, not assigned by the study. Patients in the granisetron group receive the medicine within 5 minutes before or after spinal anesthesia. The main measurement is the total dose of ephedrine used during the operation. Ephedrine is a medicine used to treat low blood pressure. The study will also record low blood pressure at scheduled measurement points and nausea and vomiting during the operation. Patient enrollment is planned from October 15 to December 15, 2026.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant women aged 18 years or older with a singleton pregnancy.

American Society of Anesthesiologists (ASA) physical status II.

Elective or emergency cesarean delivery under spinal anesthesia at Kayseri City Hospital.

Written informed consent to participate.

Disqualifiers

Age below 18 years.

Cesarean delivery performed under general or epidural anesthesia, or intraoperative conversion from spinal to general anesthesia.

Multiple pregnancy.

Serious cardiovascular disease, severe arrhythmia, or advanced heart failure.

Trial population

Adults with singleton pregnancies and ASA physical status II undergoing elective or emergency cesarean delivery under spinal anesthesia at Kayseri City Hospital between October 15 and December 15, 2026. Patients are observed according to routine clinical care, with no study-assigned treatment. The target sample is 80 participants: 40 receiving prophylactic intravenous granisetron within 5 minutes before or after spinal anesthesia and 40 receiving no prophylactic antiemetic.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Granisetron

    Drug

    Prophylactic intravenous granisetron administered during routine clinical care within 5 minutes before or 5 minutes after spinal anesthesia for cesarean delivery. The decision to use granisetron and the dose are determined by the treating anesthesiologist independently of this observational study. Actual dose and administration timing are recorded; no study-mandated dosing is imposed.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Prophylactic Granisetron1 intervention
Group B: No Prophylactic Antiemetic0 interventions

Trial outcomes

Primary outcomes

1

Total Intraoperative Ephedrine Dose

Cumulative dose of ephedrine administered to each participant during the intraoperative period, expressed in milligrams. All intraoperative ephedrine administrations are summed. Participants who receive no ephedrine have a total dose of 0 mg.

Time frame
Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.

Secondary outcomes

1

Number of Intraoperative Measurement Points With Mean Arterial Pressure Below 65 mmHg

For each participant, the number of scheduled intraoperative blood pressure measurement points at which mean arterial pressure is below 65 mmHg. Measurements are recorded at 0, 2, 5, 10, 15, 20, 25, 30, 45, and 60 minutes after spinal anesthesia while surgery is ongoing, at delivery of the baby, and at the end of surgery. This outcome is a count of low-pressure measurement points and is not a duration in minutes.

Time frame
Scheduled intraoperative assessments from spinal anesthesia administration to the end of surgery.
2

Number of Intraoperative Measurement Points With Systolic Arterial Pressure Below 90 mmHg

For each participant, the number of scheduled intraoperative blood pressure measurement points at which systolic arterial pressure is below 90 mmHg. Measurements are recorded at 0, 2, 5, 10, 15, 20, 25, 30, 45, and 60 minutes after spinal anesthesia while surgery is ongoing, at delivery of the baby, and at the end of surgery. This outcome is a count of low-pressure measurement points and is not a duration in minutes.

Time frame
Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.
3

Incidence of Intraoperative Nausea

Percentage of participants with at least one episode of nausea during the intraoperative period, based on the intraoperative case report form.

Time frame
Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.
4

Incidence of Intraoperative Vomiting

Percentage of participants with at least one episode of vomiting during the intraoperative period, based on the intraoperative case report form.

Time frame
Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kayseri City Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: