Recovery of Ventilation After General Anesthesia in Morbidly Obese Patients Who Are Treated With Opioids: A Preliminary Investigation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Probability for TcPCO2 / PaCO2 to exceed a pre-specified threshold during recovery from anesthesia.
研究概览
简要总结
This is an observational study of morbidly obese patients recovering from general anesthesia after weight-loss surgery. The investigators aim to assess ventilatory function and how this is influenced by the diagnosis of obstructive sleep apnea (OSA), baseline ventilatory status, as well as pharyngeal collapsibility of patients who are recovering from anesthesia and treated for pain with opioids. The investigators hypothesize that patients with OSA, chronic (baseline) hypoventilation and increased pharyngeal collapsibility, will be more vulnerable to opioid-induced ventilatory depression.
详细描述
Obstructive sleep apnea (OSA) increases the risk for pulmonary complications in the first 24 hours after surgery, by more than 3-fold, suggesting an enhanced sensitivity to opioid-induced ventilatory depression (OIVD), in this patient population. Obesity and OSA, two highly comorbid conditions, are common among victims of postoperative life-threatening or fatal OIVD and increased somnolence preceding the onset of a critical event, is an almost ubiquitous clinical finding.
These clinical observations are in agreement with recent evidence that decreased wakefulness is an important contributory mechanism of OIVD in OSA patients who receive opioid analgesia in the postoperative period. Studies that examined the effect of opioids on breathing in awake, sleeping, or anesthetized patients with OSA, support overall that OSA is not associated with increased sensitivity to OIVD in awake subjects. In contrast, diminished wakefulness has been shown to worsen, leave unaffected, or even slightly improve breathing and oxygenation in patients with OSA, who are treated opioids.
Decrease in the tonic activity of the pharyngeal muscles with the progression from wakefulness to sleep, contributes to increased airway resistance and the predisposition to airway occlusion. This effect of sleep on the patency of pharyngeal airway seems to be more pronounced in patients with OSA, who present with increased genioglossus muscle activity during wakefulness taken as evidence for a neural compensation to maintain adequate airflow in the presence of anatomical airway narrowing.
It can thus be suggested that during pharmacological suppression of consciousness, like when recovering from anesthesia, patients with OSA will experience more severe sleep-disordered breathing and consequently be more vulnerable to OIVD, compared to normal subjects.
Specific Aims
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) equal or greater than 35 kg/m
- •American Society of Anesthesiologists (ASA) physical status I - III patients.
- •Scheduled to undergo laparoscopic roux-en-Y gastric bypass or gastric sleeve placement surgery for weight loss.
排除标准
- •Chronic obstructive pulmonary disorder (COPD).
- •Treatment with continuous positive airway pressure (CPAP) in the past three months.
- •Severe neurological, cardiopulmonary, psychiatric, or untreated thyroid disorder.
- •Chronic pain condition that was being treated with opioids.
- •Patients with a hematocrit lower than 35%.
结局指标
主要结局
Probability for TcPCO2 / PaCO2 to exceed a pre-specified threshold during recovery from anesthesia.
时间窗: PACU period (approximate duration of about 1.5h).
Probability for TcPCO2 / PaCO2 to exceed a pre-specified threshold during recovery from anesthesia.
次要结局
- The effect of baseline ventilation on the primary outcome(PACU period (approximate duration of about 1.5h))
- The effect of the minimum PAP on the primary outcome.(PACU period (approximate duration of 1.5h))
研究者
Anthony Doufas
Professor, Department of Anesthesiology, Perioperative and Pain Medicine
Stanford University
