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临床试验/NCT06022926
NCT06022926已完成不适用

Effects of Patient Warming With Electric Blanket on Intraoperative Hemodynamics; Postoperative Nausea, Vomiting, Chills, Agitation and Pain in Laparoscopic Cholecystectomy Operation

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 128 人开始时间: 2023年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
2
主要终点
Agitation assessment

研究概览

简要总结

In our study, the investigators will investigate the effects of electric blanket heating on intraoperative hemodynamics, postoperative nausea, vomiting, shivering, agitation and pain in patients undergoing laparoscopic cholecystectomy under general anesthesia.

详细描述

Group 1: Patients warmed with electric blankets

  • Patients will be provided with electric blankets from the beginning to the end of the operation (approximately 1 hour)
  • all patients will receive standard general anesthesia
  • all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer.
  • each patient will undergo tympanic temperature measurement immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during exit from the postanesthesia recovery unit.
  • mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation, tremor and pain assessment will be performed on each patient immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during discharge from the postanesthesia recovery unit.
  • the same electric blanket was used for this group of patients
  • each time the electric blankets were set to 38 degrees and the blankets were preheated to 38 degrees approximately 30 minutes before the patients were placed on the operating table.
  • heat measurements will be made with the same tympanic heat meter device
  • heat measurements will be made by a blind anesthesiologist with at least 5 years of experience
  • Postoperative evaluations of the patients will be performed face to face.
  • patients will be warmed only during the time they are on the operating table
  • This study was followed up in the operating room and post-anesthesia recovery unit in the operating room.

Group 2: Control group (patients without warming): no electric blanket will be used, and no heating will be applied to this group of patients.

  • all patients will receive standard general anesthesia.
  • all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer.
  • each patient will undergo tympanic temperature measurement immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during exit from the postanesthesia recovery unit.
  • mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation, tremor and pain assessment will be performed on each patient immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during discharge from the postanesthesia recovery unit.
  • temperature measurements will be performed with the same tympanic thermometer device
  • heat measurements will be made by a blind anesthesiologist with at least 5 years of experience
  • Postoperative evaluations of the patients will be performed face to face.
  • This study was followed up in the operating room and post-anesthesia recovery unit in the operating room.

Statistical methods / analysis: G-Power version 3.1.9.4 (University Kiel, Germany) was used to calculate the sample size. Two-tailed alpha error was 0.05, power as 0.80 and effect size as 0.5, and according to a previous study (Comparison of different end-tidal carbon dioxide levels in preventing postoperative nausea and vomiting in gynaecological patients undergoing laparoscopic surgery. Doi: 10.1080/01443615.2020.1789961.) allocation ratio was accepted as N2/N1:1. The minimum number of patients to be included in the study was calculated as 128.

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 (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Laparoscopic cholecystectomy operation will be
  • To be between 18-65 years old.
  • Being American Society of Anesthesiologists (ASA) Classification I-II.

排除标准

  • Preoperative body temperature >37.5°C or <36°C.
  • Impaired temperature regulation such as systemic infection, mental retardation, isolated head trauma or brain injury.
  • Receiving a medication that affects thermoregulation.
  • Being American Society of Anesthesiologists (ASA) Classification >III.

结局指标

主要结局

Agitation assessment

时间窗: Will be assessed from immediately after extubation until transfer from the recovery room to the ward.

Agitation assessment with Richmond Agitation Sedation Scale (RASS). The Richmond Agitation Sedation Scale (RASS) is a 10-point scale ranging from -5 to +4.Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is "alert and calm.

次要结局

  • Pain assessment(Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.)
  • Amount of fentanyl consumed intraoperatively(during surgery])
  • Average blood pressure(Assessments will be performed at 0 minutes immediately before induction of anesthesia, 20 minutes after induction, immediately after extubation and 20 minutes in the recovery unit after anesthesia.)
  • nausea-vomiting(The evaluation will be performed at postoperative 0th hour, 2nd hour, 6th hour and 24th hour.)
  • post-operative tremor(Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.)
  • Heart rate(Assessments will be performed at 0 minutes immediately before induction of anesthesia, 20 minutes after induction, immediately after extubation and 20 minutes in the recovery unit after anesthesia.)

研究者

发起方
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Acil,MD

Anesthesiology and Reanimation Spesialist

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

研究点 (2)

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