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NCT Number: NCT03234816

Vasopressor Prophylaxis After Spinal Anesthesia

Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean delivery with promising results ; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal hypotension during cesarean delivery.

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Key information

Conditions

Cesarean Section Complications

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, Egypt

About this study

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD.

Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia).

Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known.

In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against PSH during CD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • full term singleton pregnant women
  • Scheduled for elective Cesarean Delivery
  • Aged between 18 and 40 years

Exclusion criteria

  • Cardiac morbidities
  • Hypertensive disorders of pregnancy,
  • Peripartum bleeding
  • Baseline systolic blood pressure (SBP) < 100 mmHg
  • Body mass index > 35

Treatment and study plan

Norepinephrine 0.05 mcg /Kg/min

Drug

Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia

Other names: noradrenaline infusion

Norepinephrine 0.1 mcg /Kg/min

Drug

Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia

Other names: noradrenaline infusion

Norepinephrine 0.15 mcg /Kg/min

Drug

Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia

Other names: noradrenaline infusion

Bupivacaine

Drug

10 mg Bupivacaine intra-thecal for spinal anesthesia

Other names: marcaine

Primary outcomes

  1. incidence of postspinal hypotension

    Time frame: 30 minutes after spinal anesthesia

    The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group

Secondary outcomes

  1. heart rate

    Time frame: 90 minutes after spinal anesthesia

    heart rate after spinal anesthesia measured in beat per minute

  2. vomiting

    Time frame: 120 minutes after spinal anesthesia

    incidence of vomiting after spinal anesthesia

  3. nausea

    Time frame: 120 minutes after spinal anesthesia

    incidence of nausea after spinal anesthesia

  4. ephedrine consumption

    Time frame: 60 minutes after spinal anesthesia

    total amount of ephedrine consumed after spinal anesthesia

  5. Atropine consumption

    Time frame: 60 minutes after spinal anesthesia

    total amount of atropine consumed after spinal anesthesia

  6. APGAR score

    Time frame: 10 minutes after delivery

    APGAR score of the delivered fetus

  7. incidence of severe postspinal hypotension

    Time frame: 30 minutes after spinal anesthesia

    The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group

  8. arterial blood pressure

    Time frame: 90 minutes after spinal anesthesia

    arterial blood pressure after spinal anesthesia measured in mmHg

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Vasopressor Prophylaxis After Spinal Anesthesia: A Dose Finding Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2017
Registry last updated
Jan 15, 2019

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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