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Norepinephrine Versus Ephedrine in Treatment of Hypotension During Spinal Anesthesia for Caesarean Section

Norepinephrine Versus Ephedrine for Treatment of Hypotension During Spinal Anesthesia for Caesarean Section

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03163407
Enrollment
110
Registered
2017-05-23
Start date
2016-07-01
Completion date
2017-01-31
Last updated
2017-05-23

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

Conditions

Anesthesia Complication, Cesarean Section Complications, Hypotension, Vasopressors

Brief summary

Prospective, randomized study, including full term parturients scheduled for caesarean section under spinal anesthesia. Spinal anesthesia was performed in sitting position with a 25 G spinal needle and all patients received 15 ml/kg of crystalloid intravenously during the spinal block. Baseline hemodynamics: heart rate, systolic and diastolic blood pressure were recorded before spinal anesthesia and intraoperatively. Postspinal hypotension, defined as decrease of Systolic blood pressure\>20% from the baseline value, was managed using Ephedrine increments 6 mg/3min in patients of GE group or by 5 mcg Norepinephrine/3min for the patients of GN group. Intraoperative hemodynamic data of the 2 groups were compared.

Detailed description

Prospective, randomized study including full term parturients scheduled for caesarean section under spinal anesthesia. All patients were ASA status I/II and patients with arrhythmia were excluded. Spinal anesthesia was performed in sitting position at L3-4 or L4-5. A 25 G spinal needle was used for intrathecal injection of 8 mg of hyperbaric bupivacaine, 2.5 mcg sufentanil and 100 mcg morphine. All patients received 15 ml/kg of crystalloids intravenously during the spinal block. Patients were positioned in left lateral tilt position. Baseline hemodynamics; HR, systolic (SBP) and diastolic blood pressure (DPB) were recorded before spinal anesthesia and intraoperatively (every 2 min). Post anesthesia hypotension was defined as decrease of SBP\>20% from the baseline value. If hypotension occurred, patients were randomized into 2 groups: * GE group in which hypotension were managed using ephedrine increments of 6 mg Ephedrine every 3 min until correction of SBP * GN group: patients of this group received 5mcg of Norepinephrine/3 min demographic and hemodynamic data of the two groups were compared.

Interventions

DRUGNorepinephrine

Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure

DRUGEphedrine

Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min

Sponsors

Mongi Slim Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Fully term parturients * Caesarean section under spinal anesthesia * ASA status I or II

Exclusion criteria

* Severe cardiac disease * Cardiac arrhythmia

Design outcomes

Primary

MeasureTime frameDescription
number of injectionsnumber of injections required in the first hournumber of injections required to manage the post spinal hypotension

Outcome results

None listed

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