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

Mersin University200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Spinal Anesthetic Toxicity Hypotension Drug-Induced Cesarean Section Complications

Interventions

Noradrenaline BitartrateDRUG

An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.

Bupivacaine HydrochlorideDRUG

Subarachnoid block will be performed using Bupivacaine hydrochloride (2.5 mL)

Noradrenaline BitartrateDRUG

An intravenous bolus of norepinephrine 8 mcg will be administered for management of maternal hypotension.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Woman, * ASA I-II, * 18-49 age range, * Actual body weight \>50 kg,\<90 kg * Actual height \>150cm, \<180cm * Patients undergoing surgery under elective conditions and emergency cases for non-bleeding reasons * Fasting period is appropriate, * Term pregnancy (38-42 weeks), * Patients without cardiovascular disease * Spinal block that does not reach the high level (\<T4), * Patients without diagnosis of stage 2 or higher hypertension hypertension (Stage 2 hypertension is defined as a systolic blood pressure of more than 160 mmHg and a diastolic blood pressure of more than 90 mmHg.), * Patients without vasoactive drug use, * Preop Systolic Blood Pressure \>90 mmHg, * Bleeding less than 750 ml, * Patients who signed the informed consent form to be included in the study Exclusion Criteria: * ASA III-IV, * Pregnant women outside the age range of 18-49, * Actual body weight \>90kg, \<50kg * Actual height \>180cm, \<150cm * Patients with inappropriate fasting time * Preterm pregnancy (\<38 weeks) or postterm pregnancy (\>42 weeks) * Bleeding amount more than 750 ml * Emergency surgery with bleeding (previa, placental abruption, etc.)- Pregnant with cardiovascular system disease, * High block level (\>T4) * Having a diagnosis of stage 2 or higher hypertension hypertension (Stage 2 hypertension is defined as a systolic blood pressure of more than 160 mmHg and a diastolic blood pressure of more than 90 mmHg.), * Use of vasoactive drugs, * Preop Systolic Blood Pressure \<90 mmHg * Patients who did not sign the informed consent form to be included in the study

Locations (1)

Mersin University

Mersin, Yenişehir, Turkey (Türkiye)

Outcomes

Primary Outcomes

Rate of successful management of maternal hypotension

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

Number of Noradrenaline doses administered and total dose amount

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

Secondary Outcomes

Incidence of reactive hypertension

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

Incidence of bradycardia

Patients with a heart rate less than 40 bpm

Time frame: After spinal anesthesia until the end of surgery

Evaluation of "Appearance, Pulse, Grimace, Activity, and Respiration" (APGAR) score

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

Data from ClinicalTrials.gov

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