Clinical trial NCT06512415: 10 Vs.15 mcg Norepinephrine Bolus in Severe Maternal Hypotension During Cesarean Delivery
Official title: Comparing 10- Versus 15-mcg Norepinephrine Bolus for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypotension
Spinal Anesthesia
Cesarean Section
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 184
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the incidence of successful management of severe post-spinal hypotension
timeFrame: 1 min after spinal anesthesia until 5 min after the delivery
Secondary outcomes:
measure: time to severe hypotensive episode
timeFrame: 1 min after spinal anesthesia until 5 min after the delivery
measure: reactive bradycardia
timeFrame: 1 min after spinal anesthesia until 5 min after the delivery
measure: reactive hypertension
timeFrame: 1 min after spinal anesthesia until 5 min after the delivery
measure: umbilical blood pH
timeFrame: 5 min after delivery
measure: Apgar score
timeFrame: 5 min after delivery
measure: systolic blood pressure
timeFrame: baseline, 1 min after spinal anesthesia until 5 min after the delivery
measure: heart rate
timeFrame: baseline, 1 min after spinal anesthesia until 5 min after the delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: