Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section

Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section - a Retrospective Analysis

The aim of the present study is to quantify the dose and usage of sympathomimetics used in caesarean section.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Hypotension
• Intervention / Treatment: Drug: No Granisetron; Drug: Granisetron Hydrochloride

Detailed Description

Recent metaanalysis showed significantly reduced hypotension and bradycardia in patients undergoing caesarean section in spinal anesthesia when 5-hydroxytryptamine 3 receptor antagonists were used prophylactically.

Due to this fact in our clinic the standard procedure was changed. All patients for caesarean section receive Granisetron before spinal anesthesia.

The aim of the present study is to evaluate the usage and dose of sympathomimetics during spinal anesthesia.

Therefore the investigators will evaluate approximately 120 participants who received granisetron and 120 participants who did not receive 5-hydroxytryptamine 3 receptor antagonists.

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Klinikum Goethe Universität Frankfurt am Main

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent spinal anesthesia for caesarean section in out clinic.

Description

Inclusion Criteria:

• caesarean section in spinal anesthesia

Exclusion Criteria:

• withdrawal
• incomplete documentation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No Granisetron; 120 Patients prior to changes of intern standards of caesarean section. Before march 2017 no patient undergoing elective caesarean section received Granisetron as a matter of routine.	Drug: No Granisetron; Patients who did not receive Granisetron.
With Granisetron; 120 Patients after changes of intern standards of caesarean section. After march 2017 all patient undergoing elective caesarean section received Granisetron as a matter of routine.	Drug: Granisetron Hydrochloride; Patients received Granisetron.; Other Names: Granisetron; 5-hydroxytryptamine 3 receptor antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sympathomimetics	Type of sympathomimetics during during the operation	30 minutes starting with induction of spinal anesthesia.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sympathomimetics	Cumulative dose of sympathomimetics during during the operation	30 minutes starting with induction of spinal anesthesia.
Volume substitution	Type of perioperative infused volume during the operation	30 minutes starting with induction of spinal anesthesia.
Volume substitution	Cumulative volume of perioperative infused volume during the operation	30 minutes starting with induction of spinal anesthesia.
Haemotherapy	Type of haemotherapy.	30 minutes starting with induction of spinal anesthesia.
Haemotherapy	Cumulative volume of haemotherapy.	30 minutes starting with induction of spinal anesthesia.
Duration until first application of sympathomimetics	Duration until first administration of any kind of sympathomimetics.	30 minutes starting with induction of spinal anesthesia.
Oxytocin	Duration until first administration of oxytocin.	30 minutes starting with induction of spinal anesthesia.
Oxytocin	Cumulative dose of Oxytocin.	30 minutes starting with induction of spinal anesthesia.
Uterotonic agents	Kind of uterotonic agents.	30 minutes starting with induction of spinal anesthesia.
Uterotonic agents	Cumulative dose of uterotonic agents.	30 minutes starting with induction of spinal anesthesia.

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital
• Investigators: Study Director: Kai Zacharowski, Prof. Dr. med., Department of Anesthesia, Intensive Care Medicine and Pain Therapy

Publications and helpful links

General Publications

• Raimann FJ, Baldauf HP, Louwen F, Jennewein L, Fischer D, Zacharowski K, Weber CF. Granisetron reduces the need for uterotonics but not sympathomimetics during cesarean delivery. Int J Gynaecol Obstet. 2019 Jun;145(3):361-366. doi: 10.1002/ijgo.12819. Epub 2019 Apr 15.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Sympathomimetics; Serotonin Antagonists
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Receptor Agonists; Serotonin Antagonists; Granisetron; Serotonin
• Other Study ID Numbers: XXX/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No