Comparison of Two Different Norepinephrine Bolus Doses for Management of Spinal Anesthesia-Induced Hypotension in Cesarean Section: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of successful management of maternal hypotension
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Noradrenaline Bitartrate (Drug)
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.
干预措施: Bupivacaine Hydrochloride (Drug)
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.
干预措施: Noradrenaline Bitartrate (Drug)
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.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Rate of successful management of maternal hypotension
时间窗: 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
时间窗: 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.
次要结局
- Umbilical cord blood gas analyses of fetus(The first 5 minutes after birth)
- Incidence of reactive hypertension(After spinal anesthesia until the end of surgery)
- Incidence of bradycardia(After spinal anesthesia until the end of surgery)
- Evaluation of "Appearance, Pulse, Grimace, Activity, and Respiration" (APGAR) score(The first 5 minutes after birth)
- The frequency of side effects after norepinephrine(During surgery after spinal block)
- The frequency of side effects after subarachnoid block(During surgery after spinal block)
- Effect of noradrenaline on heart rate variability(Measurements just before and 1 minute after noradrenaline administration)
研究者
Assistant Prof Levent Özdemir, M.D.
Assistant Professor
Mersin University