Manging Post Spinal Hypotension During Elective Cesarean Section
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      Spinal anesthesia is the gold standard technique for elective cesarean section. It helps to
      avoid risks regarding airway management and provides effective neuraxial postoperative
      analgesia, enabling quicker maternal recovery. Cesarean section normally require an
      anesthetic block at T4 level. So that maternal hypotension is reported to occur in up to 80%.
      This can result in significant morbidity for both the mother and fetus.The purpose of this
      study is to determine if epinephrine is as effective and safe compared to ephedrine for
      maintaining arterial blood pressure during elective cesarean section under spinal anesthesia.
      All participants will receive spinal anesthesia with a local anesthetic and sufentanil. This
      study plans to enroll 140 healthy pregnant women. Patients will be randomly assigned
      according to a computer generated system to be in one of two groups.
    

Detailed description: 
      Its a prospective double-blinded controlled trial. All participants gave a written informed
      consent. One hundred and twenty healthy women, ASA II, with singleton pregnancies at term
      scheduled for elective cesarean section under spinal anesthesia are targeted for the study.
      They are randomized to receive either epinephrine or ephedrine. Upon arrival in the operating
      room, parturient was placed in the supine position with 15° left lateral tilt with routine
      monitoring (HR, non-invasive BP, pulse oximetry, electrocardiography). Baseline BP and HR
      were computed as the mean of three consecutive BP and HR readings respectively at 1-minute
      intervals. Study participants will receive a standard spinal anesthetic consisting of 0.5%
      hyperbaric bupivacaine (2 mL) plus sufentanil (5 µg) at L3-4 vertebral interspace.

      Group A (for adrenaline group): received a prophylactic intravenous (i.v) bolus of
      Epinephrine 0.15µg/Kg at time of SA. In this group, rescue boluses of Epinephrine 0.15µg/Kg,
      were given if maternal BP decreased more than 20% from the baseline value.

      Group E (for ephedrine group): received a prophylactic i.v bolus of Ephedrine 0.1mg/Kg at
      time of SA. In this group, rescue boluses of Ephedrine 0.1mg/Kg, were given if maternal BP
      decreased more than 20% from the baseline value. Once the spinal injection was performed a
      rapid intravenous (i.v.) coload with 15mL/Kg of isotonic saline solution was started through
      a 16 G i.v. cannula (by turning the i.v. infusion to maximum and using a pressure bag
      inflated to 150 mmHg). A prophylactic bolus of vasopressor was administered at the end of
      spinal injection. After performing anesthesia, the parturient was immediately replaced in the
      supine position with a 15° left lateral table tilt until delivery of the infant. Prior to
      surgical incision, the spinal sensory level will be tested to the bilateral T6-T4 dermatomal
      level. Sensory block level was checked by cold-hot test and the Modified Bromage Scale was
      used for the assessment of motor block. The surgery was allowed when the sensory block level
      reached D4. Both the patient and the researcher's assistant (who will collect data) will be
      blinded as to the administered Epinephrine or Ephedrine bolus. Supplemental oxygen will be
      given only when the pulse oximeter reading decreased below 95%. After delivery, 5 IU of
      oxytocin diluted in 20 ml of isotonic saline solution were slowly injected over 1 minute.
      Then an i.v infusion was given (10 IU/500ml of isotonic saline solution at a flow rate of 28
      drops/min).

      Heart rate (beats/min), systolic, mean and diastolic blood pressure (mmHg) will be recorded
      every 1 min after spinal injection until the end of surgery. The incidence of hypotension
      (defined as a reduction in SBP of >20% from baseline determined just before the
      administration of spinal anesthesia) will be recorded. Reactive hypertension (defined as a
      rise of SBP >20% of baseline) will also be recorded. Bradycardia (defined as HR <50
      beats/min) will be recorded. Tachycardia (defined as a HR >140 beats/min) will also be
      recorded. Umbilical blood samples will be obtained by clamping it on both sides and a gas
      analysis will be performed to determine fetal pH, HCO3-, base excess and lactates.
      Furthermore, Apgar scores at 1 and 5 minutes after delivery will be recorded by the attending
      pediatrician, who will be unaware of the vasopressor used. The study will end when cesarean
      section is completed and the patient is transferred to the post-operative care unit.
    

Intervention name(s): Adrenaline; Ephedrine
Intervention type(s): Drug; Drug
Intervention description(s): i.v bolus of adrenaline 0.15µg/Kg rescue boluses of adrenaline 0.15µg/Kg; i.v bolus of Ephedrine 0.1mg/Kg rescue boluses of Ephedrine 0.1mg/Kg
Other intervention name(s): epinehrine
Intervention MeSH terms: Epinephrine; Racepinephrine; Ephedrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Epinephrine, Ephedrine, cesarean section, spinal anesthesia