Anesthesia; Adverse Effect, Spinal and EpiduralPhase 4NCT02477501
Ephedrine vs. Nor Epinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Section
A Phase 4 study testing Norepinephrine and Ephedrine in people with Anesthesia; Adverse Effect, Spinal and Epidural and Hypotension, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
The purpose of the study is to determine if norepinephrine is more effective as a continuous intravenous (IV) infusion compared to continuous IV ephedrine associated with crystalloid loading for 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
- Anesthesia; Adverse Effect, Spinal and Epidural, Hypotension, Complications; Cesarean Section
- What is being tested?
- Norepinephrine and Ephedrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTunisia
- Study dates
- Jan 2016to Dec 2016
- 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
- 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
- Refusal to be in study
- History of chronic opioid use (chronic pain syndrome)
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- Emergent caesarean delivery for maternal and/or fetal distress
- Preeclampsia
- 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.
Tunisia1 site
Tunis maternity and neonatology center, minisetry of public health
Tunis, 1007
About this study
Official title: Ephedrine vs. Nor-epinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Section
The purpose of the study is to determine if norepinephrine is more effective as a continuous intravenous (IV) infusion compared to continuous IV ephedrine associated with crystalloid loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Prevention of low blood pressure 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. This study plans to enroll 120 pregnant women. 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, randomized, 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 Ephedrine infusion 10 mcg/kg/min to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal.
Group B will consist of: A continuous norepinephrine infusion 0.1 mcg/kg/min to maintain systolic blood pressure (SBP) within 80-120% 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. 500 mL of Lactated Ringers solution will be administered immediately after induction of spinal anesthesia at the outflow rate of 100ml per hour.
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, 1 = nausea). Vomiting 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 baseline SBP). If the infusion must be stopped on three occasions, it will be discontinued permanently and the blood pressure maintained with Ephedrine boluses only when needed.
Bradycardia (HR less than 50 BPM) will be treated with Atropine 0.4mg IV or ephedrine 3 mg - 12 mg IV bolus.
Study participants will receive a standard spinal anesthetic consisting of 0.5% hyperbaric bupivacaine (2 mL) plus preservative free morphine (0.1 mg) and sufentanil (5 mcg) at L3-4 or L4-5. Prior to surgical incision, the spinal sensory level will be tested to the bilateral T6-T4 dermatomal level. The patients will be positioned supine with a wedge placed under the right hip to avoid aortocaval compression. Both the patient and the researcher's assistant (who will collect data) will be blinded as to the administered Ephedrine infusion or norepinephrine infusion. The study will end when cesarean section is completed and the patient transferred to the post-operative care unit.
Measured variables will include systolic, diastolic and mean non-invasive blood pressure, the number and type of interventions for control of blood pressure, heart rate, incidedence of nausea and vomiting (NV), incidence of arrhythmia and fetal cord blood analysis (pH) at delivery.
- Conditions
- Anesthesia; Adverse Effect, Spinal and Epidural, Hypotension, Complications; Cesarean Section
- Being tested
- Norepinephrine, Ephedrine
- Keywords
- Spinal anesthesia, cesarean, blood pressure, Norepinephrine, Ephedrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called Noradrenaline, Noraline
continuous infusion
EphedrineDrug
continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| Ephedrine | Active comparator | A continuous Ephedrine infusion at 10 mcg/kg/min Receives: Drug: Ephedrine |
| Norepinephrine | Active comparator | A continuous Norepinephrine infusion at 0.1 mcg/kg/min Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Blood Pressure
Measurement of systolic, diastolic and mean, non-invasive blood pressure during cesarean section with an infusion of either Ephedrine or Norepinephrine
Measured: At time of surgery (right after spinal anesthesia untill end of surgery)
Secondary outcomes (5)
Hemodynamic Parameters - heart rate
mean heart rate during cesarean section with an infusion of either Ephedrine or Norepinephrine
Measured: At time of surgery (right after spinal anesthesia untill end of surgery)
Hemodynamic Parameters - arrhythmia
incidence of arrhythmic events during cesarean section with an infusion of either Ephedrine or Norepinephrine
Measured: AT TIME OF SURGERY(right after spinal anesthesia untill end of surgery)
Vomiting
incidence of Vomiting (V) during cesarean section with an infusion of either Ephedrine or Norepinephrine. Measure will be done according to a simple scale: 0= no vomiting; 1= vomiting
Measured: AT TIME OF SURGERY (right after spinal anesthesia untill end of surgery)
mean pH of the fetal cord blood in each group
fetal cord blood analysis will be done immediately after delivery in order to determine the pH value ( ie: logarithm of the blood concentration of hydrogen ions H+)in each group
Measured: At time of birth
Nausea
incidence of Nausea (N) during cesarean section with an infusion of either Ephedrine or Norepinephrine. Measure will be done according to a simple scale: 0= no nausea; 1= nausea
Measured: AT TIME OF SURGERY (right after spinal anesthesia untill end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startJan 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; Adverse Effect, Spinal and EpiduralStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben marzouk Sofiene, University Tunis El Manar
- Investigators
- Hayen maghrebi, professor, Study director, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477501
- Sponsor's protocol ID
- UTEM NAD
- Status last verified
- Oct 2017
- First submitted
- 10 Jun 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ephedrine vs. Nor-epinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Section
- ClinicalTrials.gov ID
- NCT02477501
- Acronym / sponsor ID
- UTEM NAD
- Conditions
- Anesthesia; Adverse Effect, Spinal and Epidural, Hypotension, Complications; Cesarean Section
- Keywords
- Spinal anesthesia, cesarean, blood pressure, Norepinephrine, Ephedrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Jun 2015 (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.
The purpose of the study is to determine if norepinephrine is more effective as a continuous intravenous (IV) infusion compared to continuous IV ephedrine associated with crystalloid loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Prevention of low blood pressure 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. This study plans to enroll 120 pregnant women. 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, randomized, 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 Ephedrine infusion 10 mcg/kg/min to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal.
Group B will consist of: A continuous norepinephrine infusion 0.1 mcg/kg/min to maintain systolic blood pressure (SBP) within 80-120% 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. 500 mL of Lactated Ringers solution will be administered immediately after induction of spinal anesthesia at the outflow rate of 100ml per hour.
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, 1 = nausea). Vomiting 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 baseline SBP). If the infusion must be stopped on three occasions, it will be discontinued permanently and the blood pressure maintained with Ephedrine boluses only when needed.
Bradycardia (HR less than 50 BPM) will be treated with Atropine 0.4mg IV or ephedrine 3 mg - 12 mg IV bolus.
Study participants will receive a standard spinal anesthetic consisting of 0.5% hyperbaric bupivacaine (2 mL) plus preservative free morphine (0.1 mg) and sufentanil (5 mcg) at L3-4 or L4-5. Prior to surgical incision, the spinal sensory level will be tested to the bilateral T6-T4 dermatomal level. The patients will be positioned supine with a wedge placed under the right hip to avoid aortocaval compression. Both the patient and the researcher's assistant (who will collect data) will be blinded as to the administered Ephedrine infusion or norepinephrine infusion. The study will end when cesarean section is completed and the patient transferred to the post-operative care unit.
Measured variables will include systolic, diastolic and mean non-invasive blood pressure, the number and type of interventions for control of blood pressure, heart rate, incidedence of nausea and vomiting (NV), incidence of arrhythmia and fetal cord blood analysis (pH) at delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ephedrine | Active comparator | Drug: EphedrineA continuous Ephedrine infusion at 10 mcg/kg/min |
| Norepinephrine | Active comparator | Drug: NorepinephrineA continuous Norepinephrine infusion at 0.1 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 (12 listed)
- Use of cardiac medication or medication for blood pressure control
- Cardiovascular disease
- Multiple gestation
- Gestation diabetes requiring insulin
- Refusal to be in study
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 |
|---|---|---|
| NorepinephrineAlso: Noradrenaline, Noralinecontinuous infusion | Drug | Norepinephrine |
| Ephedrinecontinuous infusion | Drug | Ephedrine |
Primary outcome
Maternal Blood Pressure
Time frame: At time of surgery (right after spinal anesthesia untill end of surgery)
Measurement of systolic, diastolic and mean, non-invasive blood pressure during cesarean section with an infusion of either Ephedrine or Norepinephrine
5 secondary outcomes
Hemodynamic Parameters - heart rate
Time frame: At time of surgery (right after spinal anesthesia untill end of surgery)
Hemodynamic Parameters - arrhythmia
Time frame: AT TIME OF SURGERY(right after spinal anesthesia untill end of surgery)
Vomiting
Time frame: AT TIME OF SURGERY (right after spinal anesthesia untill end of surgery)
mean pH of the fetal cord blood in each group
Time frame: At time of birth
Nausea
Time frame: AT TIME OF SURGERY (right after spinal anesthesia untill end of surgery)
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 26 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Hayen maghrebi, professor study director
University Tunis El Manar
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 Norepinephrine and Ephedrine in people with Anesthesia; Adverse Effect, Spinal and Epidural and Hypotension, run by University Tunis El Manar at 1 site in Tunisia.
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 12 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 26 Oct 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 Tunisia. 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?
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?
Maternal Blood Pressure (time frame: At time of surgery (right after spinal anesthesia untill end of surgery)). 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 26 Oct 2017.