Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02354833|
Recruitment Status : Completed
First Posted : February 3, 2015
Results First Posted : January 4, 2017
Last Update Posted : January 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Effects of; Anesthesia, in Labor and Delivery||Drug: Phenylephrine Drug: Norepinephrine||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phenylephrine vs. Norepinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Delivery|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
A continuous phenylephrine infusion at 0.1 mcg/kg/min
A continuous norepinephrine infusion at 0.05 mcg/kg/min
Other Name: Levophed
- 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 ]
- Percentage of Participants Experiencing Both Nausea and Emesis [ Time Frame: At time of surgery, up to 2 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354833
|United States, West Virginia|
|West Virginia University Hospital|
|Morgantown, West Virginia, United States, 26506|