Cesarean Section Complications, Hypotension Drug-Induced, Spinal Anesthetic Toxicity
Conditions
Brief 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.
Interventions
DRUGNoradrenaline Bitartrate
An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.
DRUGBupivacaine Hydrochloride
Subarachnoid block will be performed using Bupivacaine hydrochloride (2.5 mL)
Sponsors
Mersin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful management of maternal hypotension | 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. |
| Number of Noradrenaline doses administered and total dose amount | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score | 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. |
| Umbilical cord blood gas analyses of fetus | The first 5 minutes after birth | Potential of hydrogen (pH): Normal range is between 7.35-7.45 |
| Incidence of reactive hypertension | 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). |
| The frequency of side effects after subarachnoid block | During surgery after spinal block | Side effects seen after spinal block and in patients who have not yet received noradrenaline |
| Effect of noradrenaline on heart rate variability | 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. |
| The frequency of side effects after norepinephrine | During surgery after spinal block | the number of patients with side effects (Nausea, vomiting, headache, tinnitus, arrhythmia, chest pain, etc.) |
| Incidence of bradycardia | After spinal anesthesia until the end of surgery | Patients with a heart rate less than 40 bpm |
Countries
Turkey (Türkiye)
Outcome results
None listed