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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-17

Study Completion Date

2022-10-01

Brief Summary

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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.

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Detailed Description

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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

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Spinal Anesthetic Toxicity Hypotension Drug-Induced Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bolus 6 micrograms Noradrenaline group

Mothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride.

Group Type EXPERIMENTAL

Noradrenaline Bitartrate

Intervention Type DRUG

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

Bupivacaine Hydrochloride

Intervention Type DRUG

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

Bolus 8 micrograms Noradrenaline group

Mothers in this group will receive a bolus of Norepinephrine 8 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride.

Group Type ACTIVE_COMPARATOR

Noradrenaline Bitartrate

Intervention Type DRUG

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

Bupivacaine Hydrochloride

Intervention Type DRUG

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

Interventions

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Noradrenaline Bitartrate

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

Intervention Type DRUG

Bupivacaine Hydrochloride

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

Intervention Type DRUG

Noradrenaline Bitartrate

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

Intervention Type DRUG

Bupivacaine Hydrochloride

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

Intervention Type DRUG

Other Intervention Names

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Stenor Marcaine Spinal Heavy Stenor Marcaine Spinal Heavy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes