Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03318536
• Other study ID #: XXX/17
• Status: Completed
• Start date: October 5, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: May 2018
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 1, 2018
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• caesarean section in spinal anesthesia

Exclusion Criteria:

• withdrawal

• incomplete documentation

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hypotension

Intervention

Drug:
• Granisetron Hydrochloride
Patients received Granisetron.
• No Granisetron
Patients who did not receive Granisetron.

Locations

Country	Name	City	State
Germany	Klinikum Goethe Universität Frankfurt am Main	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

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