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NCT Number: NCT06512415

10 Vs.15 mcg Norepinephrine Bolus in Severe Maternal Hypotension During Cesarean Delivery

Data regarding the optimum dose of norepinephrine for management of severe maternal hypotension is lacking. A previous report showed that the use of 10-mcg norepinephrine bolus was not superior to the 5-mcg bolus in the management of severe hypotension in addition the incidence of reactive bradycardia and hypertension was comparable in the two doses. Therefore, we hypothesize that using a higher dose of norepinephrine (15 mcg) would increase the success rate of management of severe hypotensive episode.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

Upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. Routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and the patients will receive 10 mg metoclopramide. Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval.

Lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.

After subarachnoid block, mothers will be placed in the supine position with left-lateral tilt.

Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at T4.

The patient would receive the study drug only if she developed severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading) as her first hypotensive episode. The management of the hypotensive episode will be considered successful if the systolic blood pressure is > 80% of the baseline within 2 mins of the bolus. If the bolus failed, norepinephrine bolus of 5 mcg will be given.

Any other hypotensive episode (systolic blood pressure <80% of baseline) will be managed with norepinephrine bolus of 5 mcg.

Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by IV atropine bolus (0.5 mg) will be administered.

Fluid administration will be continued up to a maximum of 1.5 liters. An oxytocin bolus (1 IU) will be delivered over five seconds after delivery then infused at a rate of 2.5-7.5 IU/hour.

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
  • American society of anesthesiologist II, scheduled for elective cesarean delivery,

Exclusion criteria

  • Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias),
  • hypertensive disorders of pregnancy,
  • peripartum bleeding,
  • coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or any contraindication to regional anesthesia,
  • baseline systolic blood pressure (SBP) < 100 mmHg

Treatment and study plan

10 mcg Norepinephrine

Drug

The assigned dose (10 mcg) will be diluted with normal saline in a 10-cc syringe

15 mcg Norepinephrine

Drug

The assigned dose (15 mcg) will be diluted with normal saline in a 10-cc syringe.

Primary outcomes

  1. the incidence of successful management of severe post-spinal hypotension

    Time frame: 1 min after spinal anesthesia until 5 min after the delivery

    systolic blood pressure >80% of baseline after drug bolus

Secondary outcomes

  1. time to severe hypotensive episode

    Time frame: 1 min after spinal anesthesia until 5 min after the delivery

    min

  2. reactive bradycardia

    Time frame: 1 min after spinal anesthesia until 5 min after the delivery

    heart rate <55 beat/min

  3. reactive hypertension

    Time frame: 1 min after spinal anesthesia until 5 min after the delivery

    systolic blood pressure >120% of baseline

  4. umbilical blood pH

    Time frame: 5 min after delivery

    umbilical artery sample

  5. Apgar score

    Time frame: 5 min after delivery

    assess Breathing effort, Heart rate, Muscle tone, Reflexes, Skin color, Each category is scored with 0, 1, or 2

  6. systolic blood pressure

    Time frame: baseline, 1 min after spinal anesthesia until 5 min after the delivery

    mmHg

  7. heart rate

    Time frame: baseline, 1 min after spinal anesthesia until 5 min after the delivery

    beat/min

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparing 10- Versus 15-mcg Norepinephrine Bolus for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery: A Randomized, Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

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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