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NCT Number: NCT03015857

Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension

Hypotension following spinal anesthesia for cesarean section is a serious problem. In this study we investigated the effect of the vasopressors phenylephrine and noradrenaline on postspinal hypotension.

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Key information

Conditions

Adverse Anesthesia Outcome

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

On arrival to the operating room, an 18g cannula will be inserted and monitors will be applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor). Patients will receive spinal anesthesia with 500 ml rapid crystalloid co-load. Ten milligrams heavy bupivacaine in addition to 20 mcg fentanyl will be injected in L3-L4 or L4-L5 interspace using 25 g spinal needle in the sitting position.

After spinal block, patients will be randomly allocated into one of two groups:

  • Phenylephrine group (n=100)
  • Norepinephrine group (n=100)

Patients who shows SBP above 140 mmHg or heart rate below 55 bpm after the first vasopressor dose will not receive the infusion. The infusion will stop if the SBP was above 140 mmHg or if the heart rate was below 55 bpm. Patients will be positioned in the supine position with left lateral tilt. Block success will be assessed using pinprick, patients with failed block will be excluded from the study. The highest sensory block level will be assessed after 5 minutes from intrathecal injection. Co-hydration will be continued till maximum of 1.5 litres.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • full term singleton parturients
  • elective cesarean sections

Exclusion criteria

  • cardiac morbidities
  • hypertensive disorders of pregnancy
  • peripartum bleeding
  • body mass index > 35 will be excluded from the study

Treatment and study plan

Phenylephrine

Drug
  • phenylephrine; a vasopressor drug given to prevent post spinal hypotension

norepinephrine

Drug
  • norepinephrine; a vasopressor drug given to prevent post spinal hypotension

Bupivacaine

Drug

intrathecal bupivacaine 10 mg will be given in both groups

Fentanyl

Drug

intrathecal fentanyl 20 mcg will be given in both groups

Placebo (normal saline)

Drug

Primary outcomes

  1. Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus)

    Time frame: 2 hours

Secondary outcomes

  1. systolic and diastolic blood pressures measured in mm Hg

    Time frame: 2 hours

  2. heart rate measured in beats per minute

    Time frame: 2 hours

  3. nausea and vomiting measured in number of attacks

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

A Comparison Between Phenylephrine and Norepinephrine Boluses in Prevention of Post-spinal Hypotension During Cesarean Delivery

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 10, 2017
Registry last updated
May 3, 2017

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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