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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06512415
Enrollment
184
Registered
2024-07-22
Start date
2024-08-31
Completion date
2024-12-31
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Hypotension, Spinal Anesthesia

Brief summary

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.

Detailed description

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.

Interventions

DRUG10 mcg Norepinephrine

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

DRUG15 mcg Norepinephrine

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the incidence of successful management of severe post-spinal hypotension1 min after spinal anesthesia until 5 min after the deliverysystolic blood pressure \>80% of baseline after drug bolus

Secondary

MeasureTime frameDescription
time to severe hypotensive episode1 min after spinal anesthesia until 5 min after the deliverymin
reactive bradycardia1 min after spinal anesthesia until 5 min after the deliveryheart rate \<55 beat/min
reactive hypertension1 min after spinal anesthesia until 5 min after the deliverysystolic blood pressure \>120% of baseline
systolic blood pressurebaseline, 1 min after spinal anesthesia until 5 min after the deliverymmHg
Apgar score5 min after deliveryassess Breathing effort, Heart rate, Muscle tone, Reflexes, Skin color, Each category is scored with 0, 1, or 2
heart ratebaseline, 1 min after spinal anesthesia until 5 min after the deliverybeat/min
umbilical blood pH5 min after deliveryumbilical artery sample

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026