Clinical trial NCT03318536: Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section
Official title: Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section - a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Cesarean Section Complications
Keywords: Serotonin Antagonists
Sympathomimetics
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 240
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent spinal anesthesia for caesarean section in out clinic.

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

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.

Eligibility criteria: Inclusion Criteria:

* caesarean section in spinal anesthesia

Exclusion Criteria:

* withdrawal
* incomplete documentation

Primary outcomes:
measure: Sympathomimetics
timeFrame: 30 minutes starting with induction of spinal anesthesia.
Secondary outcomes:
measure: Sympathomimetics
timeFrame: 30 minutes starting with induction of spinal anesthesia.
measure: Volume substitution
timeFrame: 30 minutes starting with induction of spinal anesthesia.
measure: Volume substitution
timeFrame: 30 minutes starting with induction of spinal anesthesia.
measure: Haemotherapy
timeFrame: 30 minutes starting with induction of spinal anesthesia.
measure: Haemotherapy
timeFrame: 30 minutes starting with induction of spinal anesthesia.
measure: Duration until first application of sympathomimetics
timeFrame: 30 minutes starting with induction of spinal anesthesia.
measure: Oxytocin
timeFrame: 30 minutes starting with induction of spinal anesthesia.
measure: Oxytocin
timeFrame: 30 minutes starting with induction of spinal anesthesia.
measure: Uterotonic agents
timeFrame: 30 minutes starting with induction of spinal anesthesia.
measure: Uterotonic agents
timeFrame: 30 minutes starting with induction of spinal anesthesia.
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Klinikum Goethe Universität Frankfurt am Main
state: Hessen
Study officials:
affiliation: Department of Anesthesia, Intensive Care Medicine and Pain Therapy
name: Kai Zacharowski, Prof. Dr. med.
role: STUDY_DIRECTOR
References:
citation: 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.