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Completed

NCT Number: NCT04701190

Different Noradrenaline Protocols in Post Spinal Hypotension in CS

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ankara University School of Medicine

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noradrenalin 10 microgram bolus

Drug

The noradrenaline bolus dosage of 10 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely.

Other names: NA 10B

Noradrenaline 5 microgram bolus

Drug

The noradrenaline bolus dosage of 5 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely.

Other names: NA 5B

Noradrenaline 0.1 microgram/kg/minute infusion

Drug

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.

Other names: NA 0.1I

Noradrenaline 0.05 microgram/kg/minute infusion

Drug

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.

Other names: NA 0.05I

Infusion dosage: 0.075 microgram/kg/minute infusion

Drug

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.

Other names: NA 0.075I

Spinal anesthesia

Procedure

Spinal anesthesia using 0.5% 10 milligram heavy bupivacaine plus 12.5 microgram fentanyl

Primary outcomes

  1. Incidence of maternal post spinal hypotension

    Time frame: Between the application time of spinal anesthesia and 5th minute after delivery

    The primary outcome of this study is to compare the incidences of maternal post spinal hypotension in patients administered three different noradrenaline protocols.

  2. Incidence of maternal post spinal severe hypotension

    Time frame: Between the application time of spinal anesthesia and 5th minute after delivery

    The other primary outcome of this study is to compare the incidences of maternal post spinal severe hypotension in patients administered three different noradrenaline protocols.

Secondary outcomes

  1. The incidence of post delivery maternal hypotension

    Time frame: Between 5th minute after delivery and the end of surgery

    The secondary outcome of this study is to compare the incidences of maternal post delivery hypotension in patients administered three different noradrenaline protocols.

  2. The incidence of post delivery maternal severe hypotension

    Time frame: Between 5 minute of delivery and the end of surgery

    The other secondary outcome of this study is to compare the incidences of maternal post delivery severe hypotension in patients administered three different noradrenaline protocols.

  3. The incidence of intervention applied by an anesthesiologist

    Time frame: Between the start of patient monitoring and the end of surgery

    The other secondary outcome is to determine and to compare the frequency of intervention applied by the anesthesiologist to stabilize the patients hemodynamic status.This interventions include changing the noradrenaline infusion status, administering atropine and ephedrine, according to the patients hemodynamic data.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Comparison of Different Noradrenaline Protocols to Prevent Post Spinal Hypotension During Elective Caesarean Delivery: A Randomised, Double-blind Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 8, 2021
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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