Recovery of Ventilation After General Anesthesia for Robotic-assisted Laparoscopic Nephrectomy: The Effect of Conservative Versus Liberal Oxygen Supplementation - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Transcutaneous partial pressure of carbon dioxide (TcPCO2)
研究概览
简要总结
The purpose of this randomized, controlled feasibility investigation is to characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period.
详细描述
The purpose of this study is characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period, since hyperoxemia (ie., higher than necessary partial pressure of oxygen in the arterial blood) has been associated with ventilatory depression via suppression of the hypoxic ventilatory drive.
In this feasibility randomized controlled trial, the investigators plan to estimate and compare the cumulative segment of time during which the transcutaneous partial pressure of carbon dioxide will exceed an upper limit of 45 mmHg (i.e., TcPCO2 > 45 mmHg) for the 90-min-long post-anesthesia period, between the conventional (titrated to an oxygen saturation > 96%) and the conservative (titrated to O2 saturation 90 -94%) O2 supplementation interventions.
Hypothesis
Conservative use of O2 (titrated to an SpO2: 90 - 94%), will be associated with less hypoventilation (i.e., less time spent with an TcPCO2 > 45 mmHg) during recovery from general anesthesia, compared to liberal O2 supplementation (SpO2 > 96%).
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Body mass index (BMI) less than 40 kg/m2
- •Scheduled to undergo robotic-assisted radical laparoscopic nephrectomy.
排除标准
- •Patients with a diagnosis of chronic obstructive pulmonary disorder (COPD), severe neurological, cardiopulmonary, psychiatric, or untreated thyroid disorder
- •Chronic pain condition that is being treated with opioids
- •Patients with a hematocrit lower than 30% at the end of surgery, or those with an excessive blood loss, requiring transfusion of blood products during their surgery, will be also excluded from the study.
研究组 & 干预措施
"Conservative O2 Supplementation"
Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%.
干预措施: Oxygen gas -Conservative (Other)
"Liberal O2 Supplementation"
Oxygen administration will titrated to an SpO2 > 96%.
干预措施: Oxygen gas -Liberal (Other)
结局指标
主要结局
Transcutaneous partial pressure of carbon dioxide (TcPCO2)
时间窗: Ninety -minute period immediately post-anesthesia.
The cumulative segment of time during which the transcutaneous partial pressure of carbon dioxide (TcPCO2: primary outcome) will exceed an upper limit of 45 mmHg (i.e., TcPCO2 \> 45 mmHg)
次要结局
未报告次要终点
研究者
Anthony Doufas
Professor, Department of Anesthesiology, Perioperative and Pain Medicine
Stanford University