Prevention of Maternal Hypotension During Cesarean Section With

Status Completed

Clinical Trial Summary

This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section

Clinical Trial Description

Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally. Recently, noradrenaline has been shown to be effective in maintaining blood pressure in obstetric patients. Another technique widely used to prevent hypotension is fluid administration. Current evidence suggests that the combination of fluid administration and vasoconstrictive medications should be the main strategy for prevention and management of hypotension accompanying neuraxial anesthesia procedures during cesarean section. Research is still underway in relation to the most appropriate timing for fluid administration, the most appropriate fluid volume as well as the type of fluid that should be administered. However, preloading of crystalloids seems to be inefficient as a sole strategy, while co-loading of colloids is more effective than co-loading of crystalloids for prevention of hypotension in the parturient. On the other hand, preloading and co-loading of colloids seem to be of equal effectiveness. Literature is rather scarce regarding the comparison of colloid preloading and crystalloid co-loading. The aim of this randomized study will be to investigate the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04406051
Study type	Interventional
Source	Aretaieion University Hospital
Contact
Status	Completed
Phase	N/A
Start date	May 26, 2020
Completion date	April 30, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04062994` - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Active, not recruiting	`NCT02016599` - Effects of Transitional Circulation in ELBW Infants
Recruiting	`NCT05836610` - Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates	Phase 4
Suspended	`NCT02315937` - Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'	N/A
Completed	`NCT02907931` - Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status	N/A
Completed	`NCT03215797` - Phenylephrine or Norepinephrine for a Better Hemodynamic Stability	Phase 3
Recruiting	`NCT02532270` - Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring	N/A
Completed	`NCT02802683` - Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery	Phase 4
Completed	`NCT02437799` - Dicrotic Notch and Hypotension at Caesarean Under Spinal Anaesthesia	N/A
Completed	`NCT02146898` - The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery	N/A
Not yet recruiting	`NCT01941472` - Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness	N/A
Completed	`NCT01930227` - Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients	N/A
Recruiting	`NCT01434251` - Treatment of Hypotension of Prematurity (TOHOP)	N/A
Withdrawn	`NCT01183741` - Accuracy of Non-Invasive Blood Pressure Measurement in Adults	Phase 3
Completed	`NCT01592669` - Passive Leg Raising Attenuates and Delays Tourniquet Deflation-induced Hypotension and Tachycardia	N/A
Completed	`NCT00991627` - Different Approaches to Maternal Hypotension During Cesarean Section	Phase 4
Withdrawn	`NCT00750516` - Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
Completed	`NCT00115726` - Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure	Phase 4
Recruiting	`NCT05513066` - Management Arterial Hypotension During Planned Caesarean Section, Intravenous Ephedrine/Phenylephrine Mixture Versus Intravenous Baby Noradrenaline
Completed	`NCT04089644` - Manual vs Closed-loop Control of Mean Arterial Pressure	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion. — annie-manos

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms