Clinical trial NCT04701190: Different Noradrenaline Protocols in Post Spinal Hypotension in CS
Official title: Comparison of Different Noradrenaline Protocols to Prevent Post Spinal Hypotension During Elective Caesarean Delivery: A Randomised, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotension
Cesarean Section
Anesthesia, Spinal
Keywords: Apgar Score
Pregnancy
Blood Pressure
Heart Rate
adult
female
Hypotension
Noradrenaline
Cesarean Section
Anesthesia, Spinal
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* ASA 2
* 38 +4 gestational age parturient

Exclusion Criteria:

* ASA 3-6
* Parturients with any kind of contraindication to spinal anesthesia
* Hypertensive parturients (basal systolic blood pressure above 140 mmHg)
* Parturients having basal systolic blood pressure below 100 mmHg
* Parturients having peripartum hemorrhage
* Parturients having body mass index above 40
* Parturients with a known allergic reaction to one of the study drugs
* Parturients not willing to be included into the study

Primary outcomes:
measure: Incidence of maternal post spinal hypotension
timeFrame: Between the application time of spinal anesthesia and 5th minute after delivery
measure: Incidence of maternal post spinal severe hypotension
timeFrame: Between the application time of spinal anesthesia and 5th minute after delivery
Secondary outcomes:
measure: The incidence of post delivery maternal hypotension
timeFrame: Between 5th minute after delivery and the end of surgery
measure: The incidence of post delivery maternal severe hypotension
timeFrame: Between 5 minute of delivery and the end of surgery
measure: The incidence of intervention applied by an anesthesiologist
timeFrame: Between the start of patient monitoring and the end of surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School of Medicine
Study officials:
affiliation: Associate Professor
name: Menekse Ozcelik, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vallejo MC, Attaallah AF, Elzamzamy OM, Cifarelli DT, Phelps AL, Hobbs GR, Shapiro RE, Ranganathan P. An open-label randomized controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion in prevention of spinal hypotension during cesarean delivery. Int J Obstet Anesth. 2017 Feb;29:18-25. doi: 10.1016/j.ijoa.2016.08.005. Epub 2016 Aug 28.
citation: Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, Rouk TI, Alrahmany M, Elsayad ME, Elshafaei KA, Refaie A. Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension during Cesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology. 2019 Jan;130(1):55-62. doi: 10.1097/ALN.0000000000002483.
citation: Hasanin A, Amin S, Refaat S, Habib S, Zayed M, Abdelwahab Y, Elsayad M, Mostafa M, Raafat H, Elshall A, Fatah SAE. Norepinephrine versus phenylephrine infusion for prophylaxis against post-spinal anaesthesia hypotension during elective caesarean delivery: A randomised controlled trial. Anaesth Crit Care Pain Med. 2019 Dec;38(6):601-607. doi: 10.1016/j.accpm.2019.03.005. Epub 2019 Mar 30.