Granisetron Use, Blood Pressure, and Nausea and Vomiting During Cesarean Delivery Under Spinal Anesthesia
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Salih Gale, MD
- 电话号码：+90 5372065999
- 邮箱：salihgale@gmail.com
学习地点
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Kayseri、土耳其（türkiye）、38080
- Kayseri City Hospital
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接触：
- Salih Gale, MD
- 电话号码：+90 5372065999
- 邮箱：salihgale@gmail.com
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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. |
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. |
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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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Total Intraoperative Ephedrine Dose
大体时间：Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.
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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.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Intraoperative Measurement Points With Mean Arterial Pressure Below 65 mmHg
大体时间：Scheduled intraoperative assessments from spinal anesthesia administration to the end of surgery.
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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.
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Number of Intraoperative Measurement Points With Systolic Arterial Pressure Below 90 mmHg
大体时间：Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.
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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.
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Incidence of Intraoperative Nausea
大体时间：Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.
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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.
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Incidence of Intraoperative Vomiting
大体时间：Throughout the intraoperative period, from spinal anesthesia administration to the end of surgery.
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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.
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合作者和调查者
调查人员
- 首席研究员：Salih Gale, MD、Kayseri City Hospital
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KCH-GRAN-2026-1120
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
A decision about sharing individual participant data has not yet been made.
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