Hypotension Clinical Trial
— NorPNOfficial title:
Intravenous Bolus of Phenylephrine vs. Norepinephrine in Preventing Hypotension After Spinal Anesthesia for Cesarean Section
Verified date | July 2016 |
Source | University Tunis El Manar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to determine if an intravenous bolus of phenylephrine is more effective compared to an intravenous bolus of norepinephrine 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 sufentanil. 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.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - of Anesthesiologists (ASA) Physical Status classification 1 and 2 - Pregnant women with singleton pregnancy Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
Tunisia | Tunis maternity and neonatology center, minisetry of public health | Tunis |
Lead Sponsor | Collaborator |
---|---|
University Tunis El Manar |
Tunisia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal Blood Pressure | Measurement of systolic, diastolic and mean, non-invasive blood pressure during cesarean section with an infusion of either Ephedrine or Norepinephrine | At time of surgery (right after spinal anesthesia until end of surgery) | |
Secondary | Hemodynamic Parameters - heart rate | mean heart rate during cesarean section with an infusion of either Ephedrine or Norepinephrine | At time of surgery (right after spinal anesthesia until end of surgery | |
Secondary | Hemodynamic Parameters - arrhythmia | incidence of arrhythmic events during cesarean section with an infusion of either Ephedrine or Norepinephrine | At time of surgery (right after spinal anesthesia until end of surgery) | |
Secondary | 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 | At time of surgery (right after spinal anesthesia until end of surgery) | |
Secondary | 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 | At time of birth | |
Secondary | Nausea | cesarean section with an infusion of either Ephedrine or Norepinephrine. Measure will be done according to a simple scale: 0= no nausea; 1= nausea | At time of surgery (right after spinal anesthesia until end of surgery) |
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