Different Noradrenaline Protocols in Post Spinal Hypotension in CS
Condition: Hypotension; Cesarean Section; Anesthesia, Spinal
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      The incidence of hypotension after spinal anesthesia is approximately 60% in parturients
      undergoing cesarean section. As a consequence of hypotension, nausea-vomiting, dyspnea and
      neurological deterioration in patients and low Apgar scores in newborns may occur. Therefore,
      there is an increasing interest to prevent maternal post spinal hypotension by using several
      drugs including noradrenaline given in different protocols to the patients undergoing spinal
      anesthesia for cesarean section. However, there is no conclusive answer to the question of
      which dosage is the best to prevent the maternal post spinal hypotension in literature.

      In this prospective randomized study, we aimed to compare different noradrenaline protocols
      for preventing maternal post spinal hypotension during elective cesarean delivery.
    

Detailed description: 
      One of the most important and frequent adverse effects of spinal anesthesia is post procedure
      hypotension. The emerging hypotension does not affect only the pregnant, it also does harm to
      the newborn. Therefore, an anesthesiologist should avoid and take precautions to prevent
      maternal post spinal hypotension. There is a growing body of evidence about noradrenalin
      application in the management of hemodynamic optimization of patients undergoing cesarean
      section with spinal anesthesia. However, there is no conclusive decision about the dosage and
      application protocol of noradrenaline in this patient population. In a study comparing the
      incidence of post spinal maternal hypotension given noradrenaline versus phenylephrine, the
      authors reported that both of drugs effectively controlled maternal blood pressure. The
      incidence of maternal hypotension was 30% and 32% (p= 0.8) in noradrenaline and phenylephrine
      study arms, respectively. Therefore, one can speculate that the incidence of maternal post
      spinal hypotension remains high even in patients receiving noradrenaline or phenylephrine. In
      the noradrenaline arm, only noradrenaline infusion with a dosage of 0.05 microgram/kg/minute
      without any bolus was applied to the patients. In another study, the effects of different
      noradrenaline infusion dosages with 5 microgram bolus dosage on maternal post spinal
      hypotension were investigated. The frequencies of maternal hypotension were 42.1%, 24.7% and
      26% in patients receiving 0.025, 0.05 and 0.075 microgram/kg/minute with a bolus 5 microgram
      noradrenaline, respectively. As a conclusion of this study, addition of a bolus dose of 5
      microgram noradrenaline may lower the incidence of post spinal hypotension. However, as in
      the previous study, approximately one fourth of patients still may have a post spinal
      hypotension episode. Regarding these results, the present study is planned to answer the
      question of which approach including increasing infusion or bolus dosage of noradrenaline is
      superior to ameliorate the incidence of hypotension in this population.

      In conclusion, the aim of this study is to compare three different noradrenaline protocols
      including different bolus and infusion dosages to decrease the rate of hypotension in
      patients undergoing cesarean section with spinal anesthesia.
    

Intervention name(s): Noradrenalin 10 microgram bolus; Noradrenaline 5 microgram bolus; Noradrenaline 0.1 microgram/kg/minute infusion; Noradrenaline 0.05 microgram/kg/minute infusion; Infusion dosage: 0.075 microgram/kg/minute infusion; Spinal anesthesia
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): The noradrenaline bolus dosage of 10 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely.; The noradrenaline bolus dosage of 5 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely.; Infusion dosage: 0.1 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.1 microgram/kg/minute dosage will be started.
Noradrenaline will be continued until 5 minutes after delivery of fetus.; Infusion dosage: 0.05 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.05 microgram/kg/minute dosage will be started.
Noradrenaline will be continued until 5 minutes after delivery of fetus.; nfusion dosage: 0.075 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.075 microgram/kg/minute dosage will be started.
Noradrenaline will be continued until 5 minutes after delivery of fetus.; Spinal anesthesia using 0.5% 10 milligram heavy bupivacaine plus 12.5 microgram fentanyl
Other intervention name(s): NA 10B; NA 5B; NA 0.1I; NA 0.05I; NA 0.075I
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Apgar Score; Pregnancy; Blood Pressure; Heart Rate; adult; female; Hypotension; Noradrenaline; Cesarean Section; Anesthesia, Spinal