Effects of; Anesthesia, in Labor and DeliveryPhase 4NCT02354833
Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery
A Phase 4 study testing Phenylephrine and Norepinephrine in people with Effects of; Anesthesia, in Labor and Delivery, run by West Virginia University at 1 site in United States.
Trial summary
The purpose of the study is to determine if a medication called phenylephrine, which helps to control blood pressure, is more effective as a continuous intravenous (IV) infusion compared to continuous IV norepinephrine in maintaining blood pressure during a spinal anesthetic for a cesarean delivery. 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
- Effects of; Anesthesia, in Labor and Delivery
- What is being tested?
- Phenylephrine and Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2
- Pregnant women with singleton pregnancy
- Gestational age greater than 36 weeks
- Cesarean delivery under spinal anesthesia
Who cannot join
- Use of cardiac medication or medication for blood pressure control
- Cardiovascular disease
- Multiple gestation
- Gestation diabetes requiring insulin
- History of postoperative nausea and vomiting
- Refusal to be in study
Show all 13Show fewer
- Gastric bypass surgery
- History of chronic opioid use (chronic pain syndrome)
- Emergent caesarean delivery for maternal and/or fetal distress
- Eclampsia
- Progressive neurologic disease
- Infection at insertion site
- Allergy to local anesthetics, narcotics or other study medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Hospital
Morgantown, West Virginia, 26506
About this study
Official title: Phenylephrine vs. Norepinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Delivery
The purpose of the study is to determine if a medication called phenylephrine, which helps to control blood pressure, is more effective as a continuous intravenous (IV) infusion compared to continuous IV norepinephrine in maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Good blood pressure control has been shown to decrease nausea and vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and morphine (provides long term pain control after cesarean delivery). This study plans to enroll 80 pregnant research subjects 18 years and above. Patients will be randomly assigned according to a computer generated system to be in one of two groups.
Read the detailed description
This study will be a prospective, experimental, observational, randomized open label, active treatment controlled trial.
After written and informed consent are obtained, the study participants are randomly assigned using a computer generated table to 1 of 2 treatment groups prior to cesarean delivery.
Group A will consist of: A continuous phenylephrine infusion 0.1 mcg/kg/min to maintain systolic blood pressure (SBP) within 100-120% of baseline before the spinal.
Group B will consist of: A continuous norepinephrine infusion 0.05 mcg/kg/min to maintain systolic blood pressure (SBP) within 100-120% of baseline before the spinal.
Patients will be admitted to holding area. Baseline arterial blood pressure and heart rate will be measured in supine position, with left uterine displacement. Baseline blood pressure will be calculated by taking the mean of three consecutive SBP measurements taken 5 minutes apart. IV will be placed. Intravenous ondansetron 4 mg and up to 500 mL of Lactated Ringers solution administered prior to induction of spinal anesthesia.
The primary endpoint is the number of provider interventions needed to maintain the SBP within 100-120% of baseline for both groups. The secondary endpoint is nausea measured with each provider intervention after induction of spinal anesthesia, and immediately following delivery with 11 point verbal rating scale (0 = no nausea, 10 = worst possible nausea). Patients will also be instructed to report episodes of nausea at any other time during the study. Emesis will be recorded whenever present during the surgical procedure.
Hypertensive episodes (SBP greater than 120% of baseline) will be treated with cessation of infusion. Infusion will be restarted when SBP has decreased to below the upper limit of the target range (120% of baseline SBP). If the infusion must be stopped on three occasions, it will be discontinued permanently and the blood pressure maintained with phenylephrine boluses only.
Bradycardia (HR less than 50 BPM) will be treated with glycopyrrolate 0.4mg IV or ephedrine 5 mg - 10 mg IV bolus.
Study participants will receive a standard spinal anesthetic consisting of 0.75% hyperbaric bupivacaine (1.6 mL) plus preservative free morphine (0.2 mg) and fentanyl (20 mcg) at L3-4 or L4-5 interspace (the standard of care for spinal anesthesia at Ruby Memorial Hospital). Prior to surgical incision, the spinal sensory level will be tested to the bilateral T4 dermatomal level which is necessary for cesarean section under spinal anesthesia. The patients will be positioned supine with a wedge placed under the right hip to avoid aortocaval compression. Both the patient and the clinical research assistant (who will collect data) will not be blinded as to the administered phenylephrine infusion or norepinephrine infusion. The study will end when care is transferred to the labor and delivery room nurse.
Measured variables will include blood pressure (BP), the number and type of provider interventions for control of blood pressure (BP), heart rate (HR), cardiac output (CO) as measured by a noninvasive CO monitor, APGAR scores at 1 and 5 minutes, nausea and vomiting, and fetal cord blood analysis at delivery.
- Being tested
- Phenylephrine, Norepinephrine
- Keywords
- Hypotension, Cesarean Delivery, Phenylephrine, Spinal Anesthesia, Norepinephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
NorepinephrineDrug
Also called Levophed
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Experimental | A continuous phenylephrine infusion at 0.1 mcg/kg/min Receives: Drug: Phenylephrine |
| Norepinephrine | Experimental | A continuous norepinephrine infusion at 0.05 mcg/kg/min Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Rescue Boluses to Maintain SBP
Number of rescue boluses to maintain the SBP within 100-120% of baseline
Measured: At time of surgery, up to 2 hours
Median Total Rescue Bolus Dose of Ephedrine (mg) to Maintain SBP
Measured: At time of surgery, up to 2 hours
Median Total Rescue Bolus Dose of Phenylephrine (mcg) to Maintain SBP
Measured: At time of surgery, up to 2 hours
Secondary outcomes (1)
Percentage of Participants Experiencing Both Nausea and Emesis
Measured: At time of surgery, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Effects of; Anesthesia, in Labor and DeliveryStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel C. Vallejo MD , DMD, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354833
- Sponsor's protocol ID
- 1406316590
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2015
- Last updated
- 4 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004350. doi: 10.1002/14651858.CD004350.pub3.
PubMed 23076903Djabatey EA, Barclay PM. Difficult and failed intubation in 3430 obstetric general anaesthetics. Anaesthesia. 2009 Nov;64(11):1168-71. doi: 10.1111/j.1365-2044.2009.06060.x.
PubMed 19825049Ohpasanon P, Chinachoti T, Sriswasdi P, Srichu S. Prospective study of hypotension after spinal anesthesia for cesarean section at Siriraj Hospital: incidence and risk factors, Part 2. J Med Assoc Thai. 2008 May;91(5):675-80.
PubMed 18672631Lin FQ, Qiu MT, Ding XX, Fu SK, Li Q. Ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean section: an updated meta-analysis. CNS Neurosci Ther. 2012 Jul;18(7):591-7. doi: 10.1111/j.1755-5949.2012.00345.x.
PubMed 22759268Lee A, Ngan Kee WD, Gin T. A quantitative, systematic review of randomized controlled trials of ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean delivery. Anesth Analg. 2002 Apr;94(4):920-6, table of contents. doi: 10.1097/00000539-200204000-00028.
PubMed 11916798Stewart A, Fernando R, McDonald S, Hignett R, Jones T, Columb M. The dose-dependent effects of phenylephrine for elective cesarean delivery under spinal anesthesia. Anesth Analg. 2010 Nov;111(5):1230-7. doi: 10.1213/ANE.0b013e3181f2eae1. Epub 2010 Sep 14.
PubMed 20841418Allen TK, George RB, White WD, Muir HA, Habib AS. A double-blind, placebo-controlled trial of four fixed rate infusion regimens of phenylephrine for hemodynamic support during spinal anesthesia for cesarean delivery. Anesth Analg. 2010 Nov;111(5):1221-9. doi: 10.1213/ANE.0b013e3181e1db21. Epub 2010 May 21.
PubMed 20495139Ngan Kee WD, Khaw KS, Ng FF. Comparison of phenylephrine infusion regimens for maintaining maternal blood pressure during spinal anaesthesia for Caesarean section. Br J Anaesth. 2004 Apr;92(4):469-74. doi: 10.1093/bja/aeh088. Epub 2004 Feb 20.
PubMed 14977792Doherty A, Ohashi Y, Downey K, Carvalho JC. Phenylephrine infusion versus bolus regimens during cesarean delivery under spinal anesthesia: a double-blind randomized clinical trial to assess hemodynamic changes. Anesth Analg. 2012 Dec;115(6):1343-50. doi: 10.1213/ANE.0b013e31826ac3db. Epub 2012 Sep 25.
PubMed 23011562
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenylephrine vs. Norepinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02354833
- Acronym / sponsor ID
- 1406316590
- Keywords
- Hypotension, Cesarean Delivery, Phenylephrine, Spinal Anesthesia, Norepinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Posted 4 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if a medication called phenylephrine, which helps to control blood pressure, is more effective as a continuous intravenous (IV) infusion compared to continuous IV norepinephrine in maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Good blood pressure control has been shown to decrease nausea and vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and morphine (provides long term pain control after cesarean delivery). This study plans to enroll 80 pregnant research subjects 18 years and above. Patients will be randomly assigned according to a computer generated system to be in one of two groups.
Detailed description
This study will be a prospective, experimental, observational, randomized open label, active treatment controlled trial.
After written and informed consent are obtained, the study participants are randomly assigned using a computer generated table to 1 of 2 treatment groups prior to cesarean delivery.
Group A will consist of: A continuous phenylephrine infusion 0.1 mcg/kg/min to maintain systolic blood pressure (SBP) within 100-120% of baseline before the spinal.
Group B will consist of: A continuous norepinephrine infusion 0.05 mcg/kg/min to maintain systolic blood pressure (SBP) within 100-120% of baseline before the spinal.
Patients will be admitted to holding area. Baseline arterial blood pressure and heart rate will be measured in supine position, with left uterine displacement. Baseline blood pressure will be calculated by taking the mean of three consecutive SBP measurements taken 5 minutes apart. IV will be placed. Intravenous ondansetron 4 mg and up to 500 mL of Lactated Ringers solution administered prior to induction of spinal anesthesia.
The primary endpoint is the number of provider interventions needed to maintain the SBP within 100-120% of baseline for both groups. The secondary endpoint is nausea measured with each provider intervention after induction of spinal anesthesia, and immediately following delivery with 11 point verbal rating scale (0 = no nausea, 10 = worst possible nausea). Patients will also be instructed to report episodes of nausea at any other time during the study. Emesis will be recorded whenever present during the surgical procedure.
Hypertensive episodes (SBP greater than 120% of baseline) will be treated with cessation of infusion. Infusion will be restarted when SBP has decreased to below the upper limit of the target range (120% of baseline SBP). If the infusion must be stopped on three occasions, it will be discontinued permanently and the blood pressure maintained with phenylephrine boluses only.
Bradycardia (HR less than 50 BPM) will be treated with glycopyrrolate 0.4mg IV or ephedrine 5 mg - 10 mg IV bolus.
Study participants will receive a standard spinal anesthetic consisting of 0.75% hyperbaric bupivacaine (1.6 mL) plus preservative free morphine (0.2 mg) and fentanyl (20 mcg) at L3-4 or L4-5 interspace (the standard of care for spinal anesthesia at Ruby Memorial Hospital). Prior to surgical incision, the spinal sensory level will be tested to the bilateral T4 dermatomal level which is necessary for cesarean section under spinal anesthesia. The patients will be positioned supine with a wedge placed under the right hip to avoid aortocaval compression. Both the patient and the clinical research assistant (who will collect data) will not be blinded as to the administered phenylephrine infusion or norepinephrine infusion. The study will end when care is transferred to the labor and delivery room nurse.
Measured variables will include blood pressure (BP), the number and type of provider interventions for control of blood pressure (BP), heart rate (HR), cardiac output (CO) as measured by a noninvasive CO monitor, APGAR scores at 1 and 5 minutes, nausea and vomiting, and fetal cord blood analysis at delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Experimental | Drug: PhenylephrineA continuous phenylephrine infusion at 0.1 mcg/kg/min |
| Norepinephrine | Experimental | Drug: NorepinephrineA continuous norepinephrine infusion at 0.05 mcg/kg/min |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2
- Pregnant women with singleton pregnancy
- Gestational age greater than 36 weeks
- Cesarean delivery under spinal anesthesia
Key exclusion criteria (13 listed)
- Use of cardiac medication or medication for blood pressure control
- Cardiovascular disease
- Multiple gestation
- Gestation diabetes requiring insulin
- History of postoperative nausea and vomiting
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 |
| NorepinephrineAlso: Levophed | Drug | Norepinephrine |
Primary outcome
Number of Rescue Boluses to Maintain SBP
Time frame: At time of surgery, up to 2 hours
Number of rescue boluses to maintain the SBP within 100-120% of baseline
Median Total Rescue Bolus Dose of Ephedrine (mg) to Maintain SBP
Time frame: At time of surgery, up to 2 hours
Median Total Rescue Bolus Dose of Phenylephrine (mcg) to Maintain SBP
Time frame: At time of surgery, up to 2 hours
1 secondary outcome
Percentage of Participants Experiencing Both Nausea and Emesis
Time frame: At time of surgery, up to 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23076903Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004350. doi: 10.1002/14651858.CD004350.pub3.
- Background: PubMed 19825049Djabatey EA, Barclay PM. Difficult and failed intubation in 3430 obstetric general anaesthetics. Anaesthesia. 2009 Nov;64(11):1168-71. doi: 10.1111/j.1365-2044.2009.06060.x.
- Background: PubMed 18672631Ohpasanon P, Chinachoti T, Sriswasdi P, Srichu S. Prospective study of hypotension after spinal anesthesia for cesarean section at Siriraj Hospital: incidence and risk factors, Part 2. J Med Assoc Thai. 2008 May;91(5):675-80.
- Background: PubMed 22759268Lin FQ, Qiu MT, Ding XX, Fu SK, Li Q. Ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean section: an updated meta-analysis. CNS Neurosci Ther. 2012 Jul;18(7):591-7. doi: 10.1111/j.1755-5949.2012.00345.x.
- Background: PubMed 11916798Lee A, Ngan Kee WD, Gin T. A quantitative, systematic review of randomized controlled trials of ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean delivery. Anesth Analg. 2002 Apr;94(4):920-6, table of contents. doi: 10.1097/00000539-200204000-00028.
- Background: PubMed 20841418Stewart A, Fernando R, McDonald S, Hignett R, Jones T, Columb M. The dose-dependent effects of phenylephrine for elective cesarean delivery under spinal anesthesia. Anesth Analg. 2010 Nov;111(5):1230-7. doi: 10.1213/ANE.0b013e3181f2eae1. Epub 2010 Sep 14.
- Background: PubMed 20495139Allen TK, George RB, White WD, Muir HA, Habib AS. A double-blind, placebo-controlled trial of four fixed rate infusion regimens of phenylephrine for hemodynamic support during spinal anesthesia for cesarean delivery. Anesth Analg. 2010 Nov;111(5):1221-9. doi: 10.1213/ANE.0b013e3181e1db21. Epub 2010 May 21.
- Background: PubMed 14977792Ngan Kee WD, Khaw KS, Ng FF. Comparison of phenylephrine infusion regimens for maintaining maternal blood pressure during spinal anaesthesia for Caesarean section. Br J Anaesth. 2004 Apr;92(4):469-74. doi: 10.1093/bja/aeh088. Epub 2004 Feb 20.
- Background: PubMed 23011562Doherty A, Ohashi Y, Downey K, Carvalho JC. Phenylephrine infusion versus bolus regimens during cesarean delivery under spinal anesthesia: a double-blind randomized clinical trial to assess hemodynamic changes. Anesth Analg. 2012 Dec;115(6):1343-50. doi: 10.1213/ANE.0b013e31826ac3db. Epub 2012 Sep 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Norepinephrine in people with Effects of; Anesthesia, in Labor and Delivery, run by West Virginia University 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 4 inclusion and 13 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 4 Jan 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.
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?
Yes. Results are posted in the registry (first posted 4 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Rescue Boluses to Maintain SBP (time frame: At time of surgery, up to 2 hours). The study lists 3 primary outcomes in all. 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 NCT02354833, which also lists 9 linked publications.
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 4 Jan 2017.