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Completed

NCT Number: NCT03328533

Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery

Comparison will be conducted between continuous variable infusions of Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) for prophylaxis against Post-spinal hypotension during cesarean delivery

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Key information

Conditions

Cesarean Section Complications Spinal Anesthesia

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). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. 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 PE. In this study, the investigators will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.05 mcg/Kg/min respectively for prophylaxis against PSH during CD. We used Norepinephrine Bitartrate 8 mg ampules which contains norepinephrine base of 4 mg.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Full term
  • Pregnant women
  • Scheduled for cesarean section

Exclusion criteria

  • Pre-eclampsia
  • Eclampsia
  • Bleeding
  • Cardiac dysfunction

Treatment and study plan

Phenylephrine

Drug

Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.

norepinephrine

Drug

Norepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min).

Other names: Levophed

Bupivacaine

Drug

Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.

Other names: Marcaine

Primary outcomes

  1. Incidence of post-spinal anesthesia hypotension.

    Time frame: 30 minutes after spinal anesthesia

    Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading

Secondary outcomes

  1. Incidence of severe post-spinal anesthesia hypotension

    Time frame: 30 minutes after spinal anesthesia

    Defined as the percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading

  2. Incidence of severe delivery hypotension

    Time frame: 10 minutes after delivery

    Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading

  3. Systolic blood pressure

    Time frame: 2 hours after subarachnoid block

    Systolic blood pressure measured in mmHg

  4. Heart rate

    Time frame: 2 hours after subarachnoid block

    number of heart beats per minute

  5. APGAR score for assessment of the general state of the fetus

    Time frame: 10 minutes after delivery

    APGAR score of the fetus ranging from 0 to 10. the higher the value, the better he score

  6. Incidence of reactive hypertension

    Time frame: 2 hours after spinal anesthesia

    Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading

  7. Umbilical arterial potential hydrogen (PH)

    Time frame: 10 minutes after delivery

    PH in the blood sample obtained from umbilical artery scaled from 1 to 14

  8. Umbilical arterial Partial pressure of Carbon dioxide

    Time frame: 10 minutes after delivery

    in the blood sample obtained from umbilical artery measured in mmHg

  9. incidence of nausea

    Time frame: 2 hours

    The percentage of patients with nausea

  10. Incidence of vomiting

    Time frame: 2 hours

    The percentage of patients with nausea

  11. Total phenylephrine consumption

    Time frame: 2 hours

    the total dose of phenylephrine consumed during the operation

  12. Total norepinephrine consumption

    Time frame: 2 hours

    the total dose of norepinephrine consumed during the operation

  13. Total ephedrine consumption

    Time frame: 2 hours

    the total dose of ephedrine consumed during the operation

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Norepinephrine Versus Phenylephrine Continuous Variable Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Double-blinded Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 1, 2017
Registry last updated
Jul 17, 2018

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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