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

October 1, 2026 updated by: Kayseri City Hospital

Effects of Granisetron Administered After Spinal Anesthesia on Intraoperative Hemodynamics and Nausea and Vomiting in Cesarean Deliveries: A Prospective Observational Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This single-center prospective observational cohort study will be conducted in the Department of Anesthesiology and Reanimation at Kayseri City Hospital. The planned sample comprises 80 consenting pregnant adults with singleton pregnancies and American Society of Anesthesiologists physical status II undergoing cesarean delivery under spinal anesthesia, with a target of 40 participants in each exposure group.

Anesthetic technique, antiemetic prophylaxis, fluid management, and treatment of hypotension remain at the discretion of the treating anesthesiologist as part of routine clinical care. No drug or treatment is assigned by the research protocol. The granisetron-exposed group comprises patients receiving prophylactic intravenous granisetron within the interval from 5 minutes before to 5 minutes after spinal anesthesia. The comparison group comprises patients receiving no prophylactic antiemetic. Rescue antiemetic treatment is recorded separately from prophylaxis. Granisetron dose and timing and other medications are recorded. Apfel scores are not collected.

Systolic, diastolic, and mean arterial pressure, heart rate, and oxygen saturation are recorded at baseline; 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. Hypotension is evaluated as the number of recorded intraoperative measurement points with mean arterial pressure below 65 mmHg and, separately, systolic arterial pressure below 90 mmHg. These measures are counts of low-pressure measurement points, not estimates of time spent hypotensive.

The primary outcome is the cumulative intraoperative ephedrine dose in milligrams. Other recorded data include intraoperative nausea and vomiting, rescue antiemetic use, bradycardia, other vasopressors, spinal anesthetic and opioid doses, sensory block level, demographic and obstetric characteristics, surgical times, fluid administration, and estimated blood loss. Observation is limited to the intraoperative period.

The sample size calculation described in the protocol is based on a published between-group difference in total ephedrine consumption, with an effect size of approximately 0.91, two-sided alpha of 0.05, and 95% power. The target was increased from 66 to 80 participants to allow for missing data. Continuous variables will be compared using a t-test or Mann-Whitney U test as appropriate, and categorical variables using a chi-square or Fisher exact test. Potential confounding may be assessed using multivariable regression.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • 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.
  • Routine intraoperative monitoring and a prophylactic antiemetic decision made independently by the treating anesthesiologist.

Exclusion Criteria:

  • 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.
  • Severe preeclampsia, eclampsia, or HELLP syndrome.
  • Known allergy to 5-HT3 receptor antagonists.
  • Massive intraoperative bleeding or blood transfusion.
  • Refusal to participate or absence of written informed consent.
  • Missing intraoperative hemodynamic measurements or other required study data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prophylactic Granisetron

Patients who receive prophylactic intravenous granisetron within 5 minutes before or 5 minutes after spinal anesthesia as part of routine clinical care for cesarean delivery. The decision to administer granisetron and its dose are determined by the treating anesthesiologist independently of study participation. The dose and administration time are recorded. The target group size is 40 participants.
Drug: Granisetron

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.
No Prophylactic Antiemetic

Patients undergoing cesarean delivery under spinal anesthesia who receive no prophylactic antiemetic as part of routine clinical care. Prophylaxis decisions are made by the treating anesthesiologist independently of study participation. Rescue antiemetic medication may be administered when clinically indicated and is recorded separately; rescue treatment does not redefine the initial prophylaxis group. The target group size is 40 participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Intraoperative Ephedrine Dose
Time Frame: Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Intraoperative Measurement Points With Mean Arterial Pressure Below 65 mmHg
Time Frame: Scheduled intraoperative assessments from spinal anesthesia administration to the end of surgery.

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.
Scheduled intraoperative assessments from spinal anesthesia administration to the end of surgery.
Number of Intraoperative Measurement Points With Systolic Arterial Pressure Below 90 mmHg
Time Frame: Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.

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.
Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.
Incidence of Intraoperative Nausea
Time Frame: Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.

Percentage of participants with at least one episode of nausea during the intraoperative period, based on the intraoperative case report form.
Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.
Incidence of Intraoperative Vomiting
Time Frame: Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.

Percentage of participants with at least one episode of vomiting during the intraoperative period, based on the intraoperative case report form.
Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayseri City Hospital

Investigators

  • Principal Investigator: Salih Gale, MD, Kayseri City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

October 1, 2026

First Submitted That Met QC Criteria

October 1, 2026

First Posted (Actual)

October 6, 2026

Study Record Updates

Last Update Posted (Actual)

October 6, 2026

Last Update Submitted That Met QC Criteria

October 1, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCH-GRAN-2026-1120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A decision about sharing individual participant data has not yet been made.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe