NCT05502146

Comparison of Two Different Norepinephrine Bolus Doses for Management of Spinal Anesthesia-Induced Maternal Hypotension

Comparison of Two Different Norepinephrine Bolus Doses for Management of Spinal Anesthesia-Induced Hypotension in Cesarean Section: A Randomized Controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Mersin University · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

In this study the investigators will compare two doses of norepinephrine bolus (6 mcg and 8 mcg) in management of maternal hypotensive episode after spinal block during cesarean delivery.

Detailed description

Maternal hypotension after spinal anesthesia is a common and serious complication during cesarean delivery. Despite all preventive measures, the incidence of hypotension is still around 20%. In these cases, maternal hypotension treatment is usually required using vasopressor boluses. One of the vasopressors commonly used during cesarean delivery is norepinephrine, especially recently. Although phenylephrine has long been the first choice for the prevention and treatment of maternal hypotension, its use may cause bradycardia and decreased maternal cardiac output. Norepinephrine is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; therefore, it does not cause significant cardiac depression like phenylephrine. Norepinephrine has been introduced for use during cesarean delivery with promising results. Several previous studies have investigated the efficacy of norepinephrine infusion in preventing maternal hypotension. A dose-response study investigated the best dose of Norepinephrine for the prevention of hypotension. In the dose-response study mentioned above, a dose of 6 mcg was reported as the best dose for prophylaxis against hypotension. There are very limited studies investigating the best bolus dose of norepinephrine for the treatment of maternal hypotensive episode, and the optimal dose recommendation is uncertain. In this study, researchers will investigate the efficacy and adverse effects of two bolus doses of norepinephrine (6 mcg and 8 mcg) in the management of a maternal hypotensive episode after subarachnoid block during cesarean delivery.

Conditions

• Spinal Anesthetic Toxicity
• Hypotension Drug-Induced
• Cesarean Section Complications

Interventions

Type	Name	Description
DRUG	Noradrenaline Bitartrate	An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.
DRUG	Bupivacaine Hydrochloride	Subarachnoid block will be performed using Bupivacaine hydrochloride (2.5 mL)
DRUG	Noradrenaline Bitartrate	An intravenous bolus of norepinephrine 8 mcg will be administered for management of maternal hypotension.
DRUG	Bupivacaine Hydrochloride	Subarachnoid block will be performed using Bupivacaine hydrochloride (2.5 mL)

Timeline

• Start date: 2022-08-17
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2022-08-16
• Last updated: 2023-01-18

Locations

1 site across 1 country: Turkey (Türkiye)