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NCT Number: NCT05502146

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

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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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mersin University

Mersin, Yenişehir, 33343, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noradrenaline Bitartrate

Drug

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

Other names: Stenor

Bupivacaine Hydrochloride

Drug

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

Other names: Marcaine Spinal Heavy

Primary outcomes

  1. Rate of successful management of maternal hypotension

    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.

  2. Number of Noradrenaline doses administered and total dose amount

    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.

Secondary outcomes

  1. Incidence of reactive hypertension

    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).

  2. Incidence of bradycardia

    Time frame: After spinal anesthesia until the end of surgery

    Patients with a heart rate less than 40 bpm

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

    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.

  4. Umbilical cord blood gas analyses of fetus

    Time frame: The first 5 minutes after birth

    Potential of hydrogen (pH): Normal range is between 7.35-7.45

  5. Umbilical cord blood gas analyses of fetus

    Time frame: The first 5 minutes after birth

    Partial arterial oxygen pressure (PaO2, mmHg): Normal range is between 50-100 mmHg

  6. Umbilical cord blood gas analyses of fetus

    Time frame: The first 5 minutes after birth

    Partial carbon dioxide pressure (PaCO2, mmHg): Normal range is between 35-45 mmHg

  7. Umbilical cord blood gas analyses of fetus

    Time frame: The first 5 minutes after birth

    Bicarbonate (HCO3, mEq/liter): Normal range is between 22-26 mEq/liter

  8. Umbilical cord blood gas analyses of fetus

    Time frame: The first 5 minutes after birth

    Base deficit (BE, mEq/liter): Normal range is between +2 to -2 mEq/liter

  9. The frequency of side effects after norepinephrine

    Time frame: During surgery after spinal block

    the number of patients with side effects (Nausea, vomiting, headache, tinnitus, arrhythmia, chest pain, etc.)

  10. The frequency of side effects after subarachnoid block

    Time frame: During surgery after spinal block

    Side effects seen after spinal block and in patients who have not yet received noradrenaline

  11. Effect of noradrenaline on heart rate variability

    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.

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2022
Registry last updated
Jan 18, 2023

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.

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