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临床试验/NCT07524296
NCT07524296已完成不适用

Comparison of the Effects of Spinal and General Anesthesia on the QTc Interval in Cesarean Section Patients

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年10月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Duration of QTc interval

研究概览

简要总结

The aim of this clinical study is to determine which type of anesthesia has the least effect on the electrical activity of the heart in pregnant women undergoing cesarean section. We expect to answer the following questions at the end of this study:

• In pregnant women undergoing cesarean section, does spinal anesthesia have less effect on the electrical activity of the heart, as assessed by electrocardiography (duration of QTc interval), compared to general anesthesia? Researchers will compare spinal anesthesia to general anesthesia to see if spinal anesthesia has less effect on electrocardiography.

Participants will:

  • Receive spinal anesthesia or general anesthesia for cesarean section delivery
  • Be monitored during the procedure by anesthesia monitor including electrocardiography

详细描述

Study design and setting:

Researchers designed a prospective randomized study to compare the effects of spinal anesthesia and general anesthesia on the QT interval in patients undergoing elective cesarean section delivery. The study has been approved by the local Institutional Review Board (Ethics Committee of Health Science University Haseki Training and Research Hospital, Istanbul, Türkiye; approval date: 04 October 2023; approval number: 169-2023). The research was performed acoording to the Declaration of Helsinki, and written informed consent was obtained from all participants The study was carried out at a university affiliated hospital with 700-bed in Istanbul, Türkiye between October 4 2023 and December 4 2023.

Patient selection and group allocation The patients enrolled in the study were selected from 64 consecutive pregnant women who scheduled for an elective cesarean section delivery (Figure 1). Exclusion criteria were baseline QTc >440 ms, use of medications that affect the QTc interval, family history of long QT syndrome, electrocardiographic evidence of arrhythmia and/or conduction abnormalities, or the presence of a permanent pacemaker, contraindications to spinal anesthesia (high intracranial pressure, injection site infection, coagulation disorders, severe hypovolemia, aortic and/or mitral stenosis), history of spinal surgery, congenital spinal deformity or neuromuscular disease, anemia, electrolyte imbalance, significant cardiopulmonary/hepatic/renal disesase, obesity (Body Mass Index > 30 kg/m2), an American Society of Anesthesiologists (ASA) physical classification ≥III or refusal to participate.

In the preoperative ward an intravenous (iv) line was obtained and all the patients received 10 ml/kg isotonic saline) within 20 minutes. The patients were randomly allocated to either the spinal anesthesia group (Group S) or the general anesthesia group (Group G) using sealed envelope method by an independent investigator and then were transferred to the operating room.

Anesthesia procedure In the operating room the patients received isotonic saline at a rate of 8 mL/kg/h for intravenous hydration and prexoxgenation was obtained via face mask for 3 minutes (8 L/min).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • pregnant women who scheduled for an elective cesarean section delivery

排除标准

  • baseline QTc >440 ms, use of medications that affect the QTc interval, family history of long QT syndrome, electrocardiographic evidence of arrhythmia and/or conduction abnormalities, or the presence of a permanent pacemaker, contraindications to spinal anesthesia (high intracranial pressure, injection site infection, coagulation disorders, severe hypovolemia, aortic and/or mitral stenosis), history of spinal surgery, congenital spinal deformity or neuromuscular disease, anemia, electrolyte imbalance, significant cardiopulmonary/hepatic/renal disesase, obesity (Body Mass Index > 30 kg/m2), an American Society of Anesthesiologists (ASA) physical classification ≥III or refusal to participate.

研究组 & 干预措施

Spinal anesthesia

Experimental

Patients scheduled for elective cesarean section under spinal anesthesia

干预措施: QT and QTc interval (Diagnostic Test)

General anesthesia

Active Comparator

Patients scheduled for elective cesarean section under general anesthesia

干预措施: QT and QTc interval (Diagnostic Test)

结局指标

主要结局

Duration of QTc interval

时间窗: Before the induction of general anesthesia or spinal anesthesia; 1, 5 and 10 minutes after endotrakeal intubation or spinal anesthesia; after extubation or surgery.

QT interval measurements were automatically obtained from lead II, and corrected QT (QTc) values were derived by applying Bazett's formula (QTc = QT/√RR \[s\]) via the ECG monitoring system.

次要结局

  • Hemodynamic changes(Before anesthesia induction to postoperative period)

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sinan Uzman

associate prof

Haseki Training and Research Hospital

研究点 (1)

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