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临床试验/NCT03862391
NCT03862391已完成4 期

Evaluation of the Effects of Low Flow Anesthesia on Pain and Agitation in Patients After Recovery

Sakarya University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Postanesthetic emergence agitation

研究概览

简要总结

In this study, the investigators aimed to compare postanesthetic agitation in patients undergoing laparotomic gynecological surgery under general anesthesia using sevoflurane at a fresh gas flow rate of 2 L / min with fresh gas flow rate of 0.5 L / min.

详细描述

Emergence agitation is a temporary state of mental anxiety that occurs during general anesthesia recovery. It is characterized by emergence agitation, hallucination, excitation, delusion and confusion. Increased hemorrhage due to hypertension may cause serious complications such as injury to the surgical site, patients' self-removal of surgical drains and catheters, and self-extubation. Due to these, emergence agitation results need for additional treatment, psychological stress and increased medical workload for patients and their families.

Emergence agitation after general anesthesia in adult patients was reported up to 20%. However, the ratios are very wide.

In our operating room, the investigators observed that patients with low flow anesthesia were less agitated in the recovery phase than patients with normal flow anesthesia. In our researches, the investigators have not found any studies on the agitation values of patients who underwent low flow anesthesia in the literature.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA physical status 1 and 2, underwent gynicological laparotomic surgery under general anesthesia, followed up in PACU(postoperative care unit)

排除标准

  • ASA 3 or 4, mental retardation, psychiatric disease, history of malignant hyperthermia in patient or her family, neurological disease, morbid obesity, history of asthma and follow-up in the intensive care unit.

研究组 & 干预措施

Postsurgical Pain

Active Comparator

pain is defined as unpleasant sensation that can range from mild, localized discomfort to agony.

干预措施: Analgesics (Drug)

Postanesthesia nausea and vomiting

Active Comparator

nausea defined as feeling of sickness or discomfort in the stomach that may come with an urge to vomit.

干预措施: Antiemetics (Drug)

结局指标

主要结局

Postanesthetic emergence agitation

时间窗: 30 minutes after general anesthesia recovery

Emergence agitation is a temporary state of mental anxiety that occurs during general anesthesia recovery. It is characterized by emergence agitation, hallucination, excitation, delusion and confusion. Emergence agitation is defined as the Riker sedation-agitation scale (SAS) score of 5 or more at any time in the PACU. Riker sedation-agitation scale: 7 point is 'Dangerous agitation' 6 point is 'very agitated' 5 point is 'agitated' 4 point is 'calm and cooperative' 3 point is 'sedated' 2 point is 'very sedated' 1 point is 'unarousable'

次要结局

  • postanesthetic nausea and vomiting(30 minutes after general anesthesia recovery)

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gürkan Demir

Assistant Physician

Sakarya University

研究点 (1)

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