Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section
1 other identifier
observational
240
1 country
1
Brief Summary
The aim of the present study is to quantify the dose and usage of sympathomimetics used in caesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 5, 2017
CompletedFirst Submitted
Initial submission to the registry
October 9, 2017
CompletedFirst Posted
Study publicly available on registry
October 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedMay 16, 2018
May 1, 2018
27 days
October 9, 2017
May 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sympathomimetics
Type of sympathomimetics during during the operation
30 minutes starting with induction of spinal anesthesia.
Secondary Outcomes (10)
Sympathomimetics
30 minutes starting with induction of spinal anesthesia.
Volume substitution
30 minutes starting with induction of spinal anesthesia.
Volume substitution
30 minutes starting with induction of spinal anesthesia.
Haemotherapy
30 minutes starting with induction of spinal anesthesia.
Haemotherapy
30 minutes starting with induction of spinal anesthesia.
- +5 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
Patients received Granisetron.
Eligibility Criteria
All patients who underwent spinal anesthesia for caesarean section in out clinic.
You may qualify if:
- caesarean section in spinal anesthesia
You may not qualify if:
- withdrawal
- incomplete documentation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum Goethe Universität Frankfurt am Main
Frankfurt am Main, Hesse, 60590, Germany
Related Publications (1)
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.
PMID: 30932170DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kai Zacharowski, Prof. Dr. med.
Department of Anesthesia, Intensive Care Medicine and Pain Therapy
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. Florian Raimann
Study Record Dates
First Submitted
October 9, 2017
First Posted
October 24, 2017
Study Start
October 5, 2017
Primary Completion
November 1, 2017
Study Completion
February 1, 2018
Last Updated
May 16, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share