Tam Anh TP. Ho Chi Minh General Hospital
Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam
NCT Number: NCT07327320
This clinical trial was conducted to compare the effectiveness and safety of two medications, norepinephrine and phenylephrine, in preventing hypotension during low-dose spinal anesthesia for cesarean delivery (CD). Although low-dose spinal anesthesia combined with opioids is widely used to mitigate hypotension, the incidence remains unacceptably high. Thus, vasopressors remain essential in maintaining maternal blood pressure during these procedures.
In this study, 100 women were initially assessed, with 2 excluded. The remaining 98 were randomly assigned to receive a continuous infusion of either norepinephrine or phenylephrine. During the follow-up process, 2 patients from each group were lost, resulting in 47 participants per group for final analysis.
The results showed that norepinephrine was significantly more effective, with a lower incidence of hypotension (14.9% vs. 42.6%). It also provided more stable heart rates with fewer episodes of bradycardia and less need for rescue medications. Both treatments were safe for the babies with comparable Apgar scores.
This study suggests that Norepinephrine infusion at 0.05 mcg/kg/min is more effective than phenylephrine at 0.25 mcg/kg/min in preventing hypotension during low-dose SA in CD, providing better hemodynamic stability and fewer episodes of bradycardia
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Female
Interventional
Phase 4
Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam
Upon arrival in the operating room, the parturient was monitored using standard American Society of Anesthesiologists monitors, including electrocardiography, pulse oximetry, and invasive arterial BP measurement. A large peripheral vein was cannulated using an 18-gauge intravenous catheter for the administration of fluids and medications. Baseline BP was determined by averaging three measurements taken 2 minutes apart in the supine position before SA. Low-dose SA was performed with 8 mg of bupivacaine (Marcain) combined with 20 mcg of fentanyl and 100 mcg of morphine (Opiphine). At injection, patients received 15 ml/kg of 0.9% saline IV and group-specific vasopressors:
Following SA, patients were placed in a 15° left lateral tilt and administered 4 mg of ondansetron and 4 mg of dexamethasone intravenously. The sensory block was assessed at 10 minutes; a block at or above the xiphoid was considered effective. After placental delivery, uterotonics were administered as prescribed by the obstetrician. Vasopressor infusion was stopped 5 minutes after delivery.
BP and heart rate (HR) were recorded every 2 minutes during the first 30 minutes after SA, then every 5 minutes until the end of surgery. Neonatal HR was monitored continuously, and Apgar scores were assessed at 1 and 5 minutes by a neonatologist.
Management of Hemodynamic Events and Bradycardia Hypotension was defined as systolic blood pressure (SBP) < 90 mmHg or a drop of more than 20% from baseline. Management involved increasing the vasopressor infusion rate by 20%, followed by administration of phenylephrine 50 mcg intravenously if the HR was ≥ 75 bpm, or ephedrine 6 mg IV if HR was < 75 bpm. The infusion rate was returned to baseline once SBP recovered to the target range (80-120% of baseline).
Severe hypotension (SBP < 60% of baseline) was treated using the same approach but with a higher dose of rescue vasopressors: phenylephrine 100 mcg IV or ephedrine 12 mg IV, depending on HR.
In cases of hypertension (SBP > 120% of baseline), the vasopressor infusion was reduced by 50%. If the SBP exceeded 130%, the infusion was temporarily stopped and reinitiated at 50% of the original dose once the SBP returned to the target range.
Bradycardia was defined as a HR of less than 60 bpm. Management of bradycardia was based on the patient's hemodynamic status. If bradycardia occurred without hypotension, the vasopressor infusion was temporarily discontinued, and if the HR recovered to ≥ 60 bpm, the infusion was resumed at 50% of the original dose. Persistent bradycardia (>3 minutes) was treated with atropine 0.5 mg IV, up to 3 doses. If bradycardia was associated with hypotension, ephedrine 6 mg IV was administered.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous intravenous norepinephrine infusion was administered at 0.05 mcg/kg/min, prepared by diluting 100 mcg in 50 mL of 0.9% sodium chloride
Continuous intravenous phenylephrine infusion was administered at 0.25 mcg/kg/min, prepared by diluting 500 mcg in 50 mL of 0.9% sodium chloride
Time frame: From the completion of spinal injection until 5 minutes after the neonate is delivered.
Hypotension was defined as systolic blood pressure (SBP) < 90 mmHg or a drop of more than 20% from baseline.
Time frame: From the completion of spinal injection until 5 minutes after the neonate is delivered.
Bradycardia was defined as a HR of less than 60 beat per minute.
Time frame: From the completion of spinal injection until 5 minutes after the neonate is delivered
Hypertension was defined as systolic blood pressure (SBP) > 120% of baseline.
Time frame: From the completion of spinal injection until 5 minutes after the neonate is delivered
Severe hypotension was defined as systolic blood pressure (SBP) < 60% of baseline
Time frame: From the completion of spinal injection until 5 minutes after the neonate is delivered
Requirement for rescue vasopressors (phenylephrine or ephedrine) and atropine during vasopressor administration
Time frame: From the completion of spinal injection until 5 minutes after the neonate is delivered
Maternal intraoperative nausea or vomiting during vasopressor administration
Time frame: At 1 and 5 minutes after birth
The Apgar score is a standardized clinical assessment tool used to evaluate the physical condition of newborns immediately after birth. The title "Apgar" stands for Appearance, Pulse, Grimace, Activity, and Respiration. In this study, the assessment is performed by a qualified neonatologist. Each of the five criteria is scored from 0 to 2, resulting in a total score ranging from 0 to 10.
Minimum Value: 0. Maximum Value: 10
Interpretation:
Scores 0-3: Critically low; indicates the newborn requires immediate life-saving resuscitation.
Scores 4-6: Fairly low; indicates the newborn may require some resuscitative measures or close monitoring.
Scores 7-10: Normal; indicates the newborn is in good to excellent condition. Direction: Higher scores represent a better clinical outcome for the neonate.
Tam Anh Research Institute
Other
Comparison of Continuous Norepinephrine and Phenylephrine Infusion for Preventing Hypotension During Low-Dose Spinal Anesthesia in Cesarean Delivery: A Randomized Controlled Trial
Acronym: NORPHE-CD
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