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

1 octobre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

80

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Total Intraoperative Ephedrine Dose
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Intraoperative Measurement Points With Mean Arterial Pressure Below 65 mmHg
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Kayseri City Hospital

Les enquêteurs

  • Chercheur principal: Salih Gale, MD, Kayseri City Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 octobre 2026

Achèvement primaire (Estimé)

15 décembre 2026

Achèvement de l'étude (Estimé)

15 décembre 2026

Dates d'inscription aux études

Première soumission

1 octobre 2026

Première soumission répondant aux critères de contrôle qualité

1 octobre 2026

Première publication (Réel)

6 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KCH-GRAN-2026-1120

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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