Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- Differences in Body Temperature among different treatment groups using tympanic thermometer and zero-heat-flux temperature sensor
研究概览
简要总结
Perioperative hypothermia is one of the most common anaesthetic complications, increasing the morbidity/mortality of our patients. Active prewarming with hot forced-air devices has demonstrated to be the most effective tool to prevent hypothermia, but its use is only recommended in long-term surgeries and the optimal prewarming duration has not been elucidated. Both spinal anaesthesia associated to the irrigation with liquids at low temperature instilled during transurethral resection (TUR) cause a decrease in the core temperature of the patient. This is a clinical trial comparing different time periods of prewarming in patients submitted to undergo elective transurethral resection. Our aim is to assess the effect of different time-periods of prewarming on preventing perioperative hypothermia during TUR with spinal anaesthesia. Investigators will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes. 200 patients are going to be included in this study (50 patients in each group). Measurement of temperature will be performed using a tympanic thermometer and zero-heat-flux temperature sensor. Patients will be followed throughout their hospital admission. Data will be recorded using a validated instrument and will be analysed using the statistics program R Core Team.
详细描述
Inadvertent perioperative hypothermia is probably the most common anaesthetic complication. Its appearance increases the morbidity of the surgical patient, increasing the incidence of cardiac events or perioperative blood loss and causes a greater time of recovery from anaesthesia. Prewarming is the most effective measure to prevent hypothermia and maintain intraoperative normothermia. However, prewarming in patients submitted to spinal anesthesia is still a weak recommendation and the optimal prewarming time has not been elucidated. Due to the searching of optimal prewarming time and the lack of evidence about the efficiency of prewarming in patients submitted to transurethral resection under spinal anaesthesia, the conductance of this clinical trial is justified.
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 (Care Provider, Investigator)
盲法说明
Randomization will be carried out by a collaborator investigator using a computer program (Excel 2016) when a new patient is included into the clinical trial. This collaborator investigator will tell the nurse in charge of receiving the patient in the preanesthetic room how long prewarming has to be given to the patient: 0 minutes (no prewarming), 15 minutes, 30 minutes or 45 minutes, according to the group given by the computer program. This collaborator investigator will not provide clinical care to the patient. Attending anesthesiologist will be blind to the allocation of the participants. Principal investigator will not be able to know how long prewarming will be given.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective Transurethral resection under spinal anesthesia.
- •Patients older tan 18 years old.
- •American Society of Anesthesiologists physical status classification I - III.
- •Absence of cognitive impairment.
- •Written informed consent before enrollment.
排除标准
- •Pregnancy.
- •American Society of Anesthesiologists physical status classification IV.
- •Active infection.
- •Intake of antipyretics within 24 hours before surgery.
- •Thyroid disorders.
- •Skin lesions or History of hypersensitivity to skin contact devices.
结局指标
主要结局
Differences in Body Temperature among different treatment groups using tympanic thermometer and zero-heat-flux temperature sensor
时间窗: Throughout surgery, an average of 60 minutes.
To assess the effects of prewarming in preventing drop of body temperature of patients undergoing elective transurethral resection under spinal anesthesia
次要结局
- Length of stay in postanesthetic care unit (in minutes)(Stay in Post-Anesthetic Care Unit, an average of 6 hours.)
- Postoperative pain, using visual analogue scale (from 0 to 10)(Immediate postoperative period, an average of 1 hour.)
- Postoperative shivering (using a dichotomous scale: yes or no)(Immediate postoperative period, an average of 1 hour)
研究者
Ángel Becerra
Principal Investigator, Anesthesiologist
Dr. Negrin University Hospital