Hypotension Drug-InducedPhase 4NCT02979405
Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery
A Phase 4 study testing Phenylephrine in people with Hypotension Drug-Induced, run by Universidad Industrial de Santander at 1 site in Colombia.
Trial summary
Hypotension in patients who are taken to surgery, is a very frequent complication, when the spinal anesthetical technique is used, associating this with significant adverse effects that can lead to morbidity specially in the obstetric patient. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension Drug-Induced
- What is being tested?
- Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteColombia
- Study dates
- 17 Jan 2017to 21 Feb 2017
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant subjects who are to be delivered to cesarean section under subarachnoid anesthesia
- Gestational age >37 weeks
Who cannot join
- Pregnant subjects with:
- Hipertensive disorders in pregnancy
- Acute fetal distress
- Evidence of placental dysfunction
- History of cardiovascular or cerebrovascular diseases
- hypersensitivity to phenylephrine
- Rejection of the patient
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Clinic materno infaltil San Luis
Bucaramanga, Santander Department, 68003
About this study
Official title: Effectivenes of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery: a Randomised Controlled Trial
Hypotension in patients who are taken to surgery, is a very frequent complication, when the spinal anesthetical technique is used, associating this with significant adverse effects that can lead to morbidity specially in the obstetric patient. The objective of the study is determine if the phenylephrine used of prophylactic form, achieved to prevent the appearance of hypotension in obstetric patients led to Caesarea under spinal anesthesia.
Read the detailed description
Worldwide, the caesarean section is one of the surgical procedures most frequently performed, representing a challenge to the anesthesiologist, who must administer anesthesia to the mother with minimal effects in the newborn. For this reason, spinal anesthesia emerges as an important option in the management of the obstetrical patient who is going to be taken to Caesarea. The hypotension, is one of the most frequent events adverse associated to this technical anesthetic, represented a risk of complications both, in the mother as in the fetus, by this reason the anesthesiologist must implement different strategies to treat it when this be present. From there arises the necessity of establishing if the phenylephrine, a drug used to treat hypotension, when is administed prophylactically, allows to avoid this effect. We designed a randomized clinical trial in elderly patients over 18 years who are taken to Caesarea, where they formed two groups of patients, one that will administer a prophylactic infusion of phenylephrine compared with placebo, assessing the incidence of hypotension in the two groups and the adverse events most commonly associated with this.
- Conditions
- Hypotension Drug-Induced
- Being tested
- Phenylephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Also called prophylactic Phenylephrine
prophylactic infusion of phenylephrine 40 mcg/min
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Phenylephrine 40 mcg/min, infusion during 5 minutes Receives: Drug: Phenylephrine |
| group 2 | Placebo comparator | Saline solution 21 cc, infusion during 5 minutes Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
Measured: caesarean delivery
Secondary outcomes (2)
heart rate
Measured: caesarean delivery
Newborn APGAR
Measured: Turn off of the newly born: measured to the 1 and 5 minutes from the birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start17 Jan 2017
- Primary completion20 Feb 2017
- Study completion21 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension Drug-InducedStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Industrial de Santander
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelly Johanna Puentes Vega, Universidad Industrial de Santander
- Investigators
- Hector Meléndez, Dr, Study director, Universidad Industrial de Santander
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979405
- Sponsor's protocol ID
- UIS 2016
- Status last verified
- Feb 2017
- First submitted
- 29 Nov 2016
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivenes of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02979405
- Acronym / sponsor ID
- UIS 2016
- Conditions
- Hypotension Drug-Induced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Universidad Industrial de SantanderUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 1 Dec 2016 (estimated)
- 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.
Hypotension in patients who are taken to surgery, is a very frequent complication, when the spinal anesthetical technique is used, associating this with significant adverse effects that can lead to morbidity specially in the obstetric patient. The objective of the study is determine if the phenylephrine used of prophylactic form, achieved to prevent the appearance of hypotension in obstetric patients led to Caesarea under spinal anesthesia.
Detailed description
Worldwide, the caesarean section is one of the surgical procedures most frequently performed, representing a challenge to the anesthesiologist, who must administer anesthesia to the mother with minimal effects in the newborn. For this reason, spinal anesthesia emerges as an important option in the management of the obstetrical patient who is going to be taken to Caesarea. The hypotension, is one of the most frequent events adverse associated to this technical anesthetic, represented a risk of complications both, in the mother as in the fetus, by this reason the anesthesiologist must implement different strategies to treat it when this be present. From there arises the necessity of establishing if the phenylephrine, a drug used to treat hypotension, when is administed prophylactically, allows to avoid this effect. We designed a randomized clinical trial in elderly patients over 18 years who are taken to Caesarea, where they formed two groups of patients, one that will administer a prophylactic infusion of phenylephrine compared with placebo, assessing the incidence of hypotension in the two groups and the adverse events most commonly associated with this.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: PhenylephrinePhenylephrine 40 mcg/min, infusion during 5 minutes |
| group 2 | Placebo comparator | Drug: PhenylephrineSaline solution 21 cc, infusion during 5 minutes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant subjects who are to be delivered to cesarean section under subarachnoid anesthesia
- Gestational age >37 weeks
Key exclusion criteria (7 listed)
- Hipertensive disorders in pregnancy
- Acute fetal distress
- Evidence of placental dysfunction
- History of cardiovascular or cerebrovascular diseases
- hypersensitivity to phenylephrine
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 |
|---|---|---|
| PhenylephrineAlso: prophylactic Phenylephrineprophylactic infusion of phenylephrine 40 mcg/min | Drug | group 1, group 2 |
Primary outcome
Hypotension
Time frame: caesarean delivery
2 secondary outcomes
heart rate
Time frame: caesarean delivery
Newborn APGAR
Time frame: Turn off of the newly born: measured to the 1 and 5 minutes from the birth
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 24 Feb 2017.
- 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.
Hector Meléndez, Dr study director
Universidad Industrial de Santander
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phenylephrine in people with Hypotension Drug-Induced, run by Universidad Industrial de Santander at 1 site in Colombia.
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 2 inclusion and 7 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 24 Feb 2017. 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 Colombia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hypotension (time frame: caesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.