Complications; Cesarean SectionNCT02101047
Phenylephrine Dose and Mode of Administration for Spinal Anesthesia Induced Hypotension
A study testing Phenylephrine in people with Complications; Cesarean Section and Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Three different regimens of phenylephrine are being evaluated to see if one is superior over the other in the maintenance of cardiac output while keeping normotension and/or treating hypotension experienced when receiving spinal anesthesia for cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Complications; Cesarean Section, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 31 Dec 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- scheduled for cesarean delivery age >/=18 years of age >/= 37 weeks EGA ASA status I-III
Who cannot join
- allergy to medications used in the study non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: Correlation and Effects on Cardiac Output With Intermittent Phenylephrine Administration of 50 mcg Versus 100 mcg or 100mcg/Min Prophylactic Infusion for Treatment of Hypotension in Parturients After Receiving Spinal Anesthesia for Cesarean Delivery
Three different regimens of phenylephrine are being evaluated to see if one is superior over the other in the maintenance of cardiac output while keeping normotension and/or treating hypotension experienced when receiving spinal anesthesia for cesarean delivery.
Read the detailed description
Phenylephrine will be administered in one of 3 regimens: Intermittent bolus of 50 mcg, Intermittent bolus of 100 mcg, or continuous infusion of 100 mcg/min. The infusion will contain either phenylephrine or normal saline (placebo). Subjects who are randomized to receive a bolus dose will receive placebo in the infusion. Subjects who are randomized to receive the phenylephrine infusion will have normal saline (placebo) in the bolus syringe. Baseline blood pressures will be obtained prior to surgery and then maintained using these drugs. Blood pressure and heart rate will be monitored as usual standard of care. Continuous cardiac output and hemodynamic monitoring will be obtained using CNAP (Tm) or similar (equivalent) monitoring device. Blood pressure will be maintained at 90-120% of baseline utilizing infusion and/or bolus with the 3 regimens.
- Conditions
- Complications; Cesarean Section, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- Being tested
- Phenylephrine
- Keywords
- cesarean section, hypotension, 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
| Study group | Role | What they receive |
|---|---|---|
| phenylephrine 50mcg bolus | Experimental | Phenylephrine 50 mcg bolus dosing with continuous placebo infusion Receives: Drug: Phenylephrine |
| Phenylephrine 100 mcg bolus | Experimental | Phenylephrine 100 mcg bolus dosing wtih continuous placebo infusion. Receives: Drug: Phenylephrine |
| Phenylephrine continuous infusion 100mcg/min | Experimental | Continuous phenylephrine infusion of 100 mcg/min with placebo bolus dosing. Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of cardiac output changes
Magnitude of cardiac output reduction for the duration from preoperative baseline from time of spinal anesthesia to delivery of fetus and placenta.
Measured: 0-90 minutes
Secondary outcomes (7)
provider intervention
number of provider intervention to treat abnormal hemodynamics
Measured: 0-90 minutes
vasopressor requirement
total amount of vasopressor or equivalent required
Measured: 0-90 minutes
Emetic symptoms
emetic symptoms - magnitude and/or incidence
Measured: 0-90 minutes
hypertension
incidence and magnitude
Measured: 0-90 minutes
hypotension
incidence and magnitude
Measured: 0-90 minutes
bradycardia
incidence and magnitude
Measured: 0-90 minutes
Anesthetic time
Measured: up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startAug 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Why it stopped: lack of eligible participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Pan, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101047
- Sponsor's protocol ID
- IRB 26872
- Status last verified
- Feb 2017
- First submitted
- 27 Mar 2014
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation and Effects on Cardiac Output With Intermittent Phenylephrine Administration of 50 mcg Versus 100 mcg or 100mcg/Min Prophylactic Infusion for Treatment of Hypotension in Parturients After Receiving Spinal Anesthesia for Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02101047
- Acronym / sponsor ID
- IRB 26872
- Conditions
- Complications; Cesarean Section, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- Keywords
- cesarean section, hypotension, phenylephrine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of eligible participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 1 Apr 2014 (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.
Three different regimens of phenylephrine are being evaluated to see if one is superior over the other in the maintenance of cardiac output while keeping normotension and/or treating hypotension experienced when receiving spinal anesthesia for cesarean delivery.
Detailed description
Phenylephrine will be administered in one of 3 regimens: Intermittent bolus of 50 mcg, Intermittent bolus of 100 mcg, or continuous infusion of 100 mcg/min. The infusion will contain either phenylephrine or normal saline (placebo). Subjects who are randomized to receive a bolus dose will receive placebo in the infusion. Subjects who are randomized to receive the phenylephrine infusion will have normal saline (placebo) in the bolus syringe. Baseline blood pressures will be obtained prior to surgery and then maintained using these drugs. Blood pressure and heart rate will be monitored as usual standard of care. Continuous cardiac output and hemodynamic monitoring will be obtained using CNAP (Tm) or similar (equivalent) monitoring device. Blood pressure will be maintained at 90-120% of baseline utilizing infusion and/or bolus with the 3 regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| phenylephrine 50mcg bolus | Experimental | Drug: PhenylephrinePhenylephrine 50 mcg bolus dosing with continuous placebo infusion |
| Phenylephrine 100 mcg bolus | Experimental | Drug: PhenylephrinePhenylephrine 100 mcg bolus dosing wtih continuous placebo infusion. |
| Phenylephrine continuous infusion 100mcg/min | Experimental | Drug: PhenylephrineContinuous phenylephrine infusion of 100 mcg/min with placebo bolus dosing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- scheduled for cesarean delivery age >/=18 years of age >/= 37 weeks EGA ASA status I-III
Key exclusion criteria (1 listed)
- allergy to medications used in the study non-English speaking
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 |
|---|---|---|
| Phenylephrine | Drug | Phenylephrine 100 mcg bolus, Phenylephrine continuous infusion 100mcg/min, phenylephrine 50mcg bolus |
Primary outcome
Magnitude of cardiac output changes
Time frame: 0-90 minutes
Magnitude of cardiac output reduction for the duration from preoperative baseline from time of spinal anesthesia to delivery of fetus and placenta.
7 secondary outcomes
provider intervention
Time frame: 0-90 minutes
vasopressor requirement
Time frame: 0-90 minutes
Emetic symptoms
Time frame: 0-90 minutes
hypertension
Time frame: 0-90 minutes
hypotension
Time frame: 0-90 minutes
bradycardia
Time frame: 0-90 minutes
Anesthetic time
Time frame: up to 120 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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The Mepilex Cesarean Delivery Trial / MEPIDEL
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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.
Peter Pan, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylephrine in people with Complications; Cesarean Section and Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Wake Forest University Health Sciences at 1 site in United States.
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 1 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: withdrawn, as of the sponsor's last update on 8 Nov 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Magnitude of cardiac output changes (time frame: 0-90 minutes). 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 8 Nov 2017.