Hemodynamics During Cesarean Delivery Under Spinal Anesthesia With Norepinephrine Versus Ephedrine
NCT ID: NCT07322419
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2026-01-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prophylactic Perioperative Infusion of Ephedrine Versus Noradrenaline in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia
NCT07067944
Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia
NCT05269537
Norepinephrine to Prevent Hypotension in Ceasrean Delivery
NCT05248932
Vasopressor Infusion in Cesarean Delivery
NCT03248791
Cardiac Index Changes With Ephedrine, Phenylephrine, Ondansetron and Norepinephrine During Spinal Anesthesia
NCT03421860
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Norepinephrine
Spinal Anesthesia with Bupivacaine and Fentanyl
Spinal anesthesia using 2.5 mL of 0.5% hyperbaric bupivacaine (12.5 mg) and 15 mcg of fentanyl at the L4-L5 or L3-L4 interspace
Crystalloid Coload 1000 mL
Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection
Cesarean Delivery
Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization
Transthoracic Echocardiography
Measurement of cardiac output in supine position with left lateral tilt at baseline, at 1 and 10 minutes after intrathecal injection, and immediately after delivery
Intravenous Norepinephrine Bolus
Prophylactic IV norepinephrine bolus of 6 mcg will be administered immediately after intrathecal injection, followed by rescue IV norepinephrine boluses of 3, 6, and 9 mcg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively
Ephedrine
Spinal Anesthesia with Bupivacaine and Fentanyl
Spinal anesthesia using 2.5 mL of 0.5% hyperbaric bupivacaine (12.5 mg) and 15 mcg of fentanyl at the L4-L5 or L3-L4 interspace
Crystalloid Coload 1000 mL
Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection
Cesarean Delivery
Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization
Transthoracic Echocardiography
Measurement of cardiac output in supine position with left lateral tilt at baseline, at 1 and 10 minutes after intrathecal injection, and immediately after delivery
Intravenous Ephedrine Bolus
Prophylactic IV ephedrine bolus of 6 mg will be administered immediately after intrathecal injection, followed by rescue IV ephedrine boluses of 3, 6, and 9 mg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Spinal Anesthesia with Bupivacaine and Fentanyl
Spinal anesthesia using 2.5 mL of 0.5% hyperbaric bupivacaine (12.5 mg) and 15 mcg of fentanyl at the L4-L5 or L3-L4 interspace
Crystalloid Coload 1000 mL
Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection
Cesarean Delivery
Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization
Transthoracic Echocardiography
Measurement of cardiac output in supine position with left lateral tilt at baseline, at 1 and 10 minutes after intrathecal injection, and immediately after delivery
Intravenous Norepinephrine Bolus
Prophylactic IV norepinephrine bolus of 6 mcg will be administered immediately after intrathecal injection, followed by rescue IV norepinephrine boluses of 3, 6, and 9 mcg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively
Intravenous Ephedrine Bolus
Prophylactic IV ephedrine bolus of 6 mg will be administered immediately after intrathecal injection, followed by rescue IV ephedrine boluses of 3, 6, and 9 mg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Singleton, full term pregnancy.
* Scheduled cesarean delivery under spinal anesthesia.
Exclusion Criteria
* Weight \<60 or \>110 kg.
* Body mass index (BMI) \<18.5 or ≥35 kg/m².
* Women presenting in labor.
* Any contraindication to spinal anesthesia: increased intracranial pressure, coagulopathy, or local skin infection.
* Chronic or pregnancy-induced hypertension.
* Baseline systolic blood pressure \>140 mm Hg.
* Hemoglobin \<10 g/dl.
* Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease.
* Polyhydramnios or known significant fetal abnormalities.
* Current administration of vasoactive drugs such as: beta blockers, salbutamol, or thyroxin.
19 Years
40 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mansoura University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohamed Mohamed Tawfik
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MD.25.04.982
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.