HypotensionNCT07861737
Granisetron Use, Blood Pressure, and Nausea and Vomiting During Cesarean Delivery Under Spinal Anesthesia
An observational study of Hypotension and Nausea, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypotension, Nausea, Vomiting
- What is being tested?
- Granisetron
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2026to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- Massive intraoperative bleeding or blood transfusion.
- Refusal to participate or absence of written informed consent.
- Missing intraoperative hemodynamic measurements or other required study data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kayseri City Hospital
Kayseri, 38080
Salih Gale, MD, +90 5372065999, salihgale@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypotension, Nausea, Vomiting, Cesarean Section
- Being tested
- Granisetron
- Keywords
- Granisetron, Spinal Anesthesia, Ephedrine, Prospective Cohort
- Medical subject headings
- Hypotension, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GranisetronDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Granisetron | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.
Secondary outcomes (4)
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.
Measured: Scheduled intraoperative assessments from spinal anesthesia administration to the end of surgery.
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.
Measured: Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.
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.
Measured: Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.
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.
Measured: Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Salih Gale, MD, Principal investigator, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861737
- Sponsor's protocol ID
- KCH-GRAN-2026-1120
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision about sharing individual participant data has not yet been made.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Granisetron Administered After Spinal Anesthesia on Intraoperative Hemodynamics and Nausea and Vomiting in Cesarean Deliveries: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07861737
- Acronym / sponsor ID
- KCH-GRAN-2026-1120
- Conditions
- Hypotension, Nausea, Vomiting, Cesarean Section
- Keywords
- Granisetron, Spinal Anesthesia, Ephedrine, Prospective Cohort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Granisetron | – | Drug: GranisetronPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GranisetronProphylactic 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. | Drug | Prophylactic Granisetron |
Primary outcome
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.
4 secondary outcomes
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.
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.
Incidence of Intraoperative Nausea
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided. A decision about sharing individual participant data has not yet been made.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salih Gale, MD principal investigator
Kayseri City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension and Nausea, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salih Gale, MD (+90 5372065999, salihgale@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Intraoperative Ephedrine Dose (time frame: Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.