Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section

Completed

• Conditions: Hypotension; Cesarean Section Complications
• Interventions: Drug: Granisetron Hydrochloride; Drug: No Granisetron

• Registration Number: NCT03318536
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

Study Timeline

• Study Start: 2017-10-05
• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-24
• Primary Completion: 2017-11-01
• Study Completion: 2018-02-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• caesarean section in spinal anesthesia

Exclusion Criteria

• withdrawal
• incomplete documentation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
With Granisetron	Granisetron Hydrochloride	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.
No Granisetron	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.

Primary Outcome Measures

Name	Time	Method
Sympathomimetics	30 minutes starting with induction of spinal anesthesia.	Type of sympathomimetics during during the operation

Secondary Outcome Measures

Name	Time	Method
Volume substitution	30 minutes starting with induction of spinal anesthesia.	Cumulative volume of perioperative infused volume during the operation
Haemotherapy	30 minutes starting with induction of spinal anesthesia.	Cumulative volume of haemotherapy.
Uterotonic agents	30 minutes starting with induction of spinal anesthesia.	Cumulative dose of uterotonic agents.
Sympathomimetics	30 minutes starting with induction of spinal anesthesia.	Cumulative dose of sympathomimetics during during the operation
Duration until first application of sympathomimetics	30 minutes starting with induction of spinal anesthesia.	Duration until first administration of any kind of sympathomimetics.
Oxytocin	30 minutes starting with induction of spinal anesthesia.	Cumulative dose of Oxytocin.

Trial Locations

Locations (1)

Klinikum Goethe Universität Frankfurt am Main; 🇩🇪 Frankfurt am Main, Hessen, Germany