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临床试验/NCT04614220
NCT04614220已完成不适用

The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Cesarean Section of Primigravida: A Prospective Observational Study

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Anxiety score by the visual analogue score (VAS).

研究概览

简要总结

Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence guidelines, and quality markers, regional anesthesia is preferred over general in obstetric surgery. Already a high level of anxiety is present in obstetric patients preoperatively.

详细描述

Hospital anxiety is commonly encountered, and it is reported to be seen in 60%-80% of patients who undergo surgery. There are many causes of preoperative anxiety including fear of death due to anesthesia or surgical procedure and fear of preoperative or postoperative pain.

Preoperative anxiety varies according to the patient's age, gender, educational status, history of previous operations, and medical status as well as the type of surgery and type of anesthesia. Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence guidelines, and quality markers, regional anesthesia is preferred over general in obstetric surgery. Already a high level of anxiety is present in obstetric patients preoperatively.

The anxious patients tend to prefer general anesthesia (GA) for cesarean section (CS). The patient refusal is the main contraindication for applying spinal anesthesia (SA) during CS. The anxiety can be reduced variably by non-pharmacologic and pharmacologic methods including preoperative visit, information, and music, listening to Holy Quran recitation, hypnosis, nitrous oxide, and benzodiazepines. Intravenous sedation can control the anxiety in 90% of patients subjected to spinal procedures. While the evidence supports the benefits of procedural sedation for distressed, anxious pregnant women.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • primi gravida Patients aging 20_40 years, ASA physical status I undergoing elective CS •
  • Exclusion criteria:
  • High risk pregnancy eg: pre eclampsia Absolute contra indiction for SA eg: severe anaemia Emergent CS. Patients with previous exposure to anaesthesia ( spinal or general ). Patients with educational level more than high school.

排除标准

  • 未提供

结局指标

主要结局

Anxiety score by the visual analogue score (VAS).

时间窗: Preoperative

the visual analog score (VAS) from 0- 10, where 10 is the maximum anxiety level

Acceptance rate to spinal anaethesia during CS

时间窗: Preoperative .

Questionnaire : The first decision for anesthesia, either spinal or general, will be recorded. Then, patients who refuse SA and prefer general anesthesia (GA) will be consulted again as regards SA with presence of close relative for comfortable spinal procedure. Their last choice is the second decision that determines the final type of anesthesia to be implemented.

Satisfaction rating scale

时间窗: 6 hours Postoperative

Scale ( 1 - 10 ) 1is the lowest satisfaction 10 is the best satisfaction

次要结局

  • AGE(Preoperative)
  • Height(Preoperative)
  • Mean arterial blood pressure MAP (mmHg)(Preoperative)
  • WEIGHT(Preoperative)
  • heart rate (beat/min)(Preoperative)
  • peripheral oxygen saturation (Spo2)(Preoperative)

研究者

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

Mahmoud Hussein Bahr

Lecturer in Department of Anaesthesia , surgical ICU and pain management (Faculty of medicine)

Beni-Suef University

研究点 (1)

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