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临床试验/NCT01858727
NCT01858727已完成不适用

The Effect of Preoperative Warming on Postoperative Hypothermia in TURP Surgery

Ankara Diskapi Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年11月1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
36
试验地点
1
主要终点
Perioperative measurements of core temperature (centigrade ° C)

研究概览

简要总结

36 patients American society of anesthesiology (ASA) physical status I,II and III undergoing general anesthesia for elective transurethral resection of the prostate (TUR-P) surgery will be included in the study. Patients will be randomized into two groups; first group(control group) and second group (forced-air warming). Resistive heating will start when patients are transferred to the operating room table; forced-air warming will start before preoperative 30 minute.

详细描述

The primary aim of this study was to compare the effect of prewarming on perioperative hypothermia in elderly patients undergoing TURP under general anesthesia. In addition, we aimed to evaluate the effects of prewarming on hemodynamic variables, PACU output time, tremor, patient comfort and satisfaction. The investigators plan to enroll 36 patients in 2 groups. Body temperature will be measured at the core temperature, hemodynamic variables. Shivering will be graded by visual inspection. Thermal discomfort scale, patient satisfaction will be evaluated. The investigators hypothesize will decrease the forced air prewarming incidence of perioperative hypothermia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients aged 50-85 years undergoing general anesthesia for TURP surgery
  • ASA physical status I and III patients
  • Body mass index between 15 and 36 kg/m2
  • General anesthesia time is 30-90 minutes

排除标准

  • without written consent,
  • inadequate Turkish comprehension,
  • known impaired thermoregulation or thyroid disorders,
  • severe hypertension (systolic blood pressure [SBP]>180 mmHg or diastolic blood pressure [DBP] > 110 mmHg in the operating suite admission),
  • an angiotensin-converting enzyme inhibitor/angiotensin II receptor antagonist on the day of surgery,
  • secondary hypertension (e.g., renal artery stenosis, pheochromocytoma, Cushing's syndrome),
  • vascular disease,
  • poor cutaneous perfusion,
  • serious skin lesions
  • baseline temperature ≥37.5°C (degrees centigrade)

研究组 & 干预措施

forced air warming group

Active Comparator

30 minutes before the preoperative will use forced air warming.

干预措施: forced air warming group (Other)

forced air warming group

Active Comparator

30 minutes before the preoperative will use forced air warming.

干预措施: control group (Other)

control group

No Intervention

do not active heating group

结局指标

主要结局

Perioperative measurements of core temperature (centigrade ° C)

时间窗: 2-3 hours

After the operation patients will be admitted to the PACU. Here, body temperature will be assessed and the incidence of hypothermic patients (body temperature \< 36°C)will be measured.

次要结局

  • Number of patients with postoperative shivering(2-3 hours)
  • Evaluation of hemodynamic variables (arterial blood pressure)(2-3 hours)
  • Evaluation of hemodynamic variables (heart rate)(2-3 hours)

研究者

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

Fatma Kavak Akelma

Dr. fatma kavak akelma

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

研究点 (1)

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