HypotensionNCT03318536
Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section
An observational study of Hypotension and Cesarean Section Complications, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The aim of the present study is to quantify the dose and usage of sympathomimetics used in caesarean section. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension, Cesarean Section Complications
- What is being tested?
- Granisetron Hydrochloride and No Granisetron
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- 5 Oct 2017to 1 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients who underwent spinal anesthesia for caesarean section in out clinic.
Who may be able to join
- caesarean section in spinal anesthesia
Who cannot join
- withdrawal
- incomplete documentation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Goethe Universität Frankfurt am Main
Frankfurt am Main, Hesse, 60590
About this study
Official title: Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section - a Retrospective Analysis
The aim of the present study is to quantify the dose and usage of sympathomimetics used in caesarean section.
Read the 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.
- Conditions
- Hypotension, Cesarean Section Complications
- Being tested
- Granisetron Hydrochloride, No Granisetron
- Keywords
- Serotonin Antagonists, Sympathomimetics
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granisetron HydrochlorideDrug
Also called Granisetron, 5-hydroxytryptamine 3 receptor antagonist
Patients received Granisetron.
No GranisetronDrug
Patients who did not receive Granisetron.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: No 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. Receives: Drug: Granisetron Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathomimetics
Type of sympathomimetics during during the operation
Measured: 30 minutes starting with induction of spinal anesthesia.
Secondary outcomes (10)
Sympathomimetics
Cumulative dose of sympathomimetics during during the operation
Measured: 30 minutes starting with induction of spinal anesthesia.
Volume substitution
Type of perioperative infused volume during the operation
Measured: 30 minutes starting with induction of spinal anesthesia.
Volume substitution
Cumulative volume of perioperative infused volume during the operation
Measured: 30 minutes starting with induction of spinal anesthesia.
Haemotherapy
Type of haemotherapy.
Measured: 30 minutes starting with induction of spinal anesthesia.
Haemotherapy
Cumulative volume of haemotherapy.
Measured: 30 minutes starting with induction of spinal anesthesia.
Duration until first application of sympathomimetics
Duration until first administration of any kind of sympathomimetics.
Measured: 30 minutes starting with induction of spinal anesthesia.
Oxytocin
Duration until first administration of oxytocin.
Measured: 30 minutes starting with induction of spinal anesthesia.
Oxytocin
Cumulative dose of Oxytocin.
Measured: 30 minutes starting with induction of spinal anesthesia.
Uterotonic agents
Kind of uterotonic agents.
Measured: 30 minutes starting with induction of spinal anesthesia.
Uterotonic agents
Cumulative dose of uterotonic agents.
Measured: 30 minutes starting with induction of spinal anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start5 Oct 2017
- Primary completion1 Nov 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Florian Raimann, Johann Wolfgang Goethe University Hospital
- Investigators
- Kai Zacharowski, Prof. Dr. med., Study director, Department of Anesthesia, Intensive Care Medicine and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318536
- Sponsor's protocol ID
- XXX/17
- Status last verified
- May 2018
- First submitted
- 9 Oct 2017
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30932170
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section - a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03318536
- Acronym / sponsor ID
- XXX/17
- Conditions
- Hypotension, Cesarean Section Complications
- Keywords
- Serotonin Antagonists, Sympathomimetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Granisetron | – | Drug: No Granisetron120 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. |
| With Granisetron | – | Drug: Granisetron Hydrochloride120 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent spinal anesthesia for caesarean section in out clinic.
Key inclusion criteria (1 listed)
- caesarean section in spinal anesthesia
Key exclusion criteria (2 listed)
- withdrawal
- incomplete documentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granisetron HydrochlorideAlso: Granisetron, 5-hydroxytryptamine 3 receptor antagonistPatients received Granisetron. | Drug | With Granisetron |
| No GranisetronPatients who did not receive Granisetron. | Drug | No Granisetron |
Primary outcome
Sympathomimetics
Time frame: 30 minutes starting with induction of spinal anesthesia.
Type of sympathomimetics during during the operation
10 secondary outcomes
Sympathomimetics
Time frame: 30 minutes starting with induction of spinal anesthesia.
Volume substitution
Time frame: 30 minutes starting with induction of spinal anesthesia.
Volume substitution
Time frame: 30 minutes starting with induction of spinal anesthesia.
Haemotherapy
Time frame: 30 minutes starting with induction of spinal anesthesia.
Haemotherapy
Time frame: 30 minutes starting with induction of spinal anesthesia.
Duration until first application of sympathomimetics
Time frame: 30 minutes starting with induction of spinal anesthesia.
Oxytocin
Time frame: 30 minutes starting with induction of spinal anesthesia.
Oxytocin
Time frame: 30 minutes starting with induction of spinal anesthesia.
Uterotonic agents
Time frame: 30 minutes starting with induction of spinal anesthesia.
Uterotonic agents
Time frame: 30 minutes starting with induction of spinal anesthesia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Derived from this study: PubMed 30932170Raimann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Zacharowski, Prof. Dr. med. study director
Department of Anesthesia, Intensive Care Medicine and Pain Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension and Cesarean Section Complications, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sympathomimetics (time frame: 30 minutes starting with induction of spinal anesthesia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03318536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.