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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Salih Gale, MD
- 電話番号：+90 5372065999
- メール：salihgale@gmail.com
研究場所
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-
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Kayseri、トルコ（Türkiye）、38080
- Kayseri City Hospital
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コンタクト：
- Salih Gale, MD
- 電話番号：+90 5372065999
- メール：salihgale@gmail.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total Intraoperative Ephedrine Dose
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Intraoperative Measurement Points With Mean Arterial Pressure Below 65 mmHg
時間枠：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
時間枠：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.
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Incidence of Intraoperative Nausea
時間枠：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
時間枠：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.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Salih Gale, MD、Kayseri City Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- KCH-GRAN-2026-1120
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
A decision about sharing individual participant data has not yet been made.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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