Association of Analgesia Nociceptive Index With Preoperative Anxiety: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Validation of ANI score for prediction of post-operative pain 48 hours
研究概览
简要总结
The management and prediction of pain is one of the most crucial jobs for anesthetists. It has been shown that a patient's ability to remain calm during stressful situations is related to their post-surgical pain scores. The MetroDoloris Analgesia Nociception Index (ANI) monitor is a heart-rate monitor that provides us with a number which reflects a patient's state of relaxation (or parasympathetic tone). For this reason, the investigators are testing whether ANI can be used as a metric for perioperative anxiety, and a predictive tool for pain after c-sections.
详细描述
Purpose: The purpose of the study is to evaluate the MDoloris ANI monitor as an effective tool for objectively measuring perioperative stress, and as a prediction of post-operative pain.
Hypothesis: High perioperative anxiety scores, high post-operative pain scores, high post-operative anesthetic dosing, and high incidence of provider intervention will be positively correlated with frequency and magnitude of changes in the ANI score.
Justification: Anesthetists are constantly monitoring a patient's heart rate during caesarean sections. This is standard care, and this monitoring provides useful information about a patient's level of sedation, analgesia, and comfort. The ANI monitor takes more heart rate information through two electrodes placed on a patient's chest, and non-invasively provides more information by which anesthetists can improve the patient's standard of care.
Primary Objective: To determine whether the ANI monitor is a viable means of measuring perioperative anxiety during C-sections.
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •19 years of age or older.
- •Patient receiving an uncomplicated, scheduled caesarean section
- •Patient with a normal sinus rhythm
排除标准
- •Presentation with cardiac arrhythmia
- •Contraindications to neuraxial analgesia (ex. patient refusal, infection at the site of injection, uncorrected hypovolemia, allergy, increased intracranial pressure, coagulopathy, sepsis, fixed cardiac output states, or indeterminate neurological status), or risk factors likely to affect placement or function of the spinal needle (ex. previous back surgery, significant uncorrected scoliosis, or morbid obesity (BMI >40))
- •History of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids
- •Current or historical evidence of any significant medical conditions, including diseases of pregnancy
- •Clinical settings in which general anesthesia may be preferable (ex. patient with failed regional anesthetic, patient with history of bleeding, fetal shoulder dystocia etc.)
- •Anticipated fetal abnormalities
结局指标
主要结局
Validation of ANI score for prediction of post-operative pain 48 hours
时间窗: Pain scores at 48 hours
Association between frequency and magnitude of changes in the ANI with patient's reported VAS evoked and resting pain scores at 24h and 48h. Evoked pain is defined as pain experienced from moving from a supine position (where resting pain VAS is measured) to seated position.
Validation of Analgesia Nociception Index (ANI) score for objective measurement of anxiety
时间窗: 25 minutes perioperatively
Association between frequency and magnitude of changes in ANI during the perioperative time period with patient's reported perioperative anxiety scores
Validation of ANI score for prediction of post-operative pain 24 hours
时间窗: Pain scores at 24 hours
Association between frequency and magnitude of changes in the ANI with patient's reported VAS evoked and resting pain scores at 24h and 48h. Evoked pain is defined as pain experienced from moving from a supine position (where resting pain VAS is measured) to seated position.
次要结局
- Validation of ANI score for prediction of post-operative opioid requirements at 24 hours(Opioid use collected during followup at 24 hours)
- Validation of ANI score for prediction of post-operative opioid requirements at 48 hours(Opioid use collected during followup at 48 hours)
- Absolute ANI score validation at 24 hours(Pain score recorded 24 hours post partum)
- Absolute ANI score validation at 48 hours(Pain score recorded at 48 hours post partum)
- Percent variability in ANI(ANI score recorded for 25 minutes perioperatively)
研究者
Anthony Chau
Principle Investigator
University of British Columbia