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临床试验/NCT05136040
NCT05136040已完成不适用

Comparison Of The Effects Of Two Different Low-Doses Of Isobaric Bupivacaine On Intraoperative Hemodynamics In Spinal Anesthesia During Cesarean Section: A Randomized Controlled Trial

Ataturk University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年10月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
The primary aim of study was to compare the effects of two different low-dose bupivacaine used in spinal anesthesia on intraoperative systolic and diastolic blood pressure (mmHg) in cesarean section operations.

研究概览

简要总结

The primary aim of this study was to compare the effects of two different low-dose bupivacaine used in spinal anesthesia on intraoperative hemodynamics in cesarean section operations.Investigators think that low-dose bupivacaine and fentanyl mixture applied in cesarean section cause fewer hemodynamic changes,provide adequate anesthesia and analgesia quality,cause fewer side effects,and postoperatively,patients may return to their daily activities more quickly.This study was conducted on 80 pregnant women undergo an elective cesarean section.Patients were randomly allocated in GrupA and GroupB. Combined spinal-epidural anesthesia was performed in the sitting position using the needle-inside-needle technique.After cerebrospinal fluid flow was observed, GroupA patients were given a solution containing 5 mg isobaric bupivacaine+15 µg fentanyl (1.3 ml),and Group B was administered a solution containing 7 mg isobaric bupivacaine+15 µg fentanyl (1.7ml).Hypotension,bradycardia,duration of analgesia,postoperative nausea and vomiting were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patients with hypertension induced by emergency obstetric surgery
  • Significant systemic disease,
  • Multiple pregnancies,
  • Fetal or placental abnormality,
  • Hypersensitivity or allergy history to the drugs to be used in the study
  • Contraindicated neuraxial anesthesia,
  • Infection at or around the region to be anesthetized,
  • Coagulation abnormalities
  • Patients unable to decide or unwilling to participate in the study

研究组 & 干预措施

Group İzobarik bupivakain (5 mg) + fentanil

Active Comparator

Patients were given a solution containing 5 mg isobaric bupivacaine + 15 µg fentanyl (1.3 ml)

干预措施: Bupivacaine (Drug)

Group İzobarik bupivakain (7 mg) + fentanil

Active Comparator

Patients were givena solution containing 7 mg isobaric bupivacaine + 15 µg fentanyl (1.7 ml)

干预措施: Bupivacaine (Drug)

结局指标

主要结局

The primary aim of study was to compare the effects of two different low-dose bupivacaine used in spinal anesthesia on intraoperative systolic and diastolic blood pressure (mmHg) in cesarean section operations.

时间窗: during cesarean procedure

Intraoperatif hemodynamics

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aysenur Dostbil

Principal Investigator

Ataturk University

研究点 (1)

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