Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section

NCT ID: NCT03318536

Last Updated: 2018-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-05

Study Completion Date

2018-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypotension Cesarean Section Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No Granisetron

Intervention Type DRUG

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.

Granisetron Hydrochloride

Intervention Type DRUG

Patients received Granisetron.

Interventions

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Granisetron Hydrochloride

Patients received Granisetron.

Intervention Type DRUG

No Granisetron

Patients who did not receive Granisetron.

Intervention Type DRUG

Other Intervention Names

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Granisetron 5-hydroxytryptamine 3 receptor antagonist

Eligibility Criteria

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Inclusion Criteria

* caesarean section in spinal anesthesia

Exclusion Criteria

* withdrawal
* incomplete documentation
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Florian Raimann

Dr. med. Florian Raimann

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kai Zacharowski, Prof. Dr. med.

Role: STUDY_DIRECTOR

Department of Anesthesia, Intensive Care Medicine and Pain Therapy

Locations

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Klinikum Goethe Universität Frankfurt am Main

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 30932170 (View on PubMed)

Other Identifiers

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XXX/17

Identifier Type: -

Identifier Source: org_study_id

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