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Completed

NCT Number: NCT03318536

Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section

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

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Key information

Conditions

Hypotension Cardiovascular Diseases Cesarean Section Complications Vascular Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Klinikum Goethe Universität Frankfurt am Main

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • caesarean section in spinal anesthesia

Exclusion criteria

  • withdrawal
  • incomplete documentation

Treatment and study plan

granisetron hydrochloride

Drug

Patients received Granisetron.

Other names: Granisetron, 5-hydroxytryptamine 3 receptor antagonist

No Granisetron

Drug

Patients who did not receive Granisetron.

Primary outcomes

  1. Sympathomimetics

    Time frame: 30 minutes starting with induction of spinal anesthesia.

    Type of sympathomimetics during during the operation

Secondary outcomes

  1. Sympathomimetics

    Time frame: 30 minutes starting with induction of spinal anesthesia.

    Cumulative dose of sympathomimetics during during the operation

  2. Volume substitution

    Time frame: 30 minutes starting with induction of spinal anesthesia.

    Type of perioperative infused volume during the operation

  3. Volume substitution

    Time frame: 30 minutes starting with induction of spinal anesthesia.

    Cumulative volume of perioperative infused volume during the operation

  4. Haemotherapy

    Time frame: 30 minutes starting with induction of spinal anesthesia.

    Type of haemotherapy.

  5. Haemotherapy

    Time frame: 30 minutes starting with induction of spinal anesthesia.

    Cumulative volume of haemotherapy.

  6. Duration until first application of sympathomimetics

    Time frame: 30 minutes starting with induction of spinal anesthesia.

    Duration until first administration of any kind of sympathomimetics.

  7. Oxytocin

    Time frame: 30 minutes starting with induction of spinal anesthesia.

    Duration until first administration of oxytocin.

  8. Oxytocin

    Time frame: 30 minutes starting with induction of spinal anesthesia.

    Cumulative dose of Oxytocin.

  9. Uterotonic agents

    Time frame: 30 minutes starting with induction of spinal anesthesia.

    Kind of uterotonic agents.

  10. Uterotonic agents

    Time frame: 30 minutes starting with induction of spinal anesthesia.

    Cumulative dose of uterotonic agents.

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 24, 2017
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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