Mersin University
Mersin, Yenişehir, 33343, Turkey (Türkiye)
NCT Number: NCT05502146
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.
Looking for future studies?
Notify Me18 year–49 year
Female
Interventional
Phase 4
Mersin, Yenişehir, 33343, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.
Other names: Stenor
Subarachnoid block will be performed using Bupivacaine hydrochloride (2.5 mL)
Other names: Marcaine Spinal Heavy
Time frame: After spinal anesthesia until the end of surgery
Number of patients with successful management of a maternal hypotensive episode (defined as systolic blood pressure greater than 80% of baseline measurement and systolic blood pressure greater than 90 mmHg) Successful management is considered to be successful management if blood pressure does not fall below 90 mmHg and 80% of baseline measurement within 6 minutes after norepinephrine administration after hypotension develops.
Time frame: After spinal anesthesia until the end of surgery
Evaluation of the number of bolus noradrenaline doses and the total dose required for the treatment of maternal hypotension after spinal block.
Time frame: After spinal anesthesia until the end of surgery
Number of patients with reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading after administration of norepinephrine bolus).
Time frame: After spinal anesthesia until the end of surgery
Patients with a heart rate less than 40 bpm
Time frame: The first 5 minutes after birth
The minimum score that can be obtained from this scale is 0 and the maximum is 10 points.
Scoring will be calculated at 1 and 5 minutes immediately after birth. A score of 9 to 10 is consistent with a better clinical outcome, while a score of 8 or less will be considered a poor clinical outcome.
Time frame: The first 5 minutes after birth
Potential of hydrogen (pH): Normal range is between 7.35-7.45
Time frame: The first 5 minutes after birth
Partial arterial oxygen pressure (PaO2, mmHg): Normal range is between 50-100 mmHg
Time frame: The first 5 minutes after birth
Partial carbon dioxide pressure (PaCO2, mmHg): Normal range is between 35-45 mmHg
Time frame: The first 5 minutes after birth
Bicarbonate (HCO3, mEq/liter): Normal range is between 22-26 mEq/liter
Time frame: The first 5 minutes after birth
Base deficit (BE, mEq/liter): Normal range is between +2 to -2 mEq/liter
Time frame: During surgery after spinal block
the number of patients with side effects (Nausea, vomiting, headache, tinnitus, arrhythmia, chest pain, etc.)
Time frame: During surgery after spinal block
Side effects seen after spinal block and in patients who have not yet received noradrenaline
Time frame: Measurements just before and 1 minute after noradrenaline administration
Comparison of the rates of change in heart rate in measurements before and after two different bolus doses of noradrenaline.
Mersin University
Other
Comparison of Two Different Norepinephrine Bolus Doses for Management of Spinal Anesthesia-Induced Hypotension in Cesarean Section: A Randomized Controlled Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03792906
Cesarean Section Complications, Spinal Anesthetic Toxicity
Cairo, Egypt
View Trial DetailsNCT04001881
Spinal Anesthetic Toxicity
Athens, Attica, Greece
View Trial DetailsNCT03266250
Inferior Vena Cava Abnormality, Intraoperative Complications
Athens, Attica, Greece
View Trial DetailsNCT06892665
Cardiovascular Diseases, Cesarean Section Complications
Cheras, Kuala Lumpur, Malaysia
View Trial Details