How Fasting Duration Before Cesarean Section Affects the Quality of Recovery Score (ObsQoR-11)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Obstetric Quality of Recovery (ObsQoR-11)
研究概览
简要总结
This study will evaluate the effect of fasting duration and elective c-section start time on the overall quality of recovery. Patients will be seen 24 hours after surgery to answer 11 questions on their overall recovery after surgery. Several factors will be tracked to determine their effect on recovery, with the primary variable of interesting
详细描述
This is a prospective observational study aiming to evaluate the impact of fasting time before cesarean section on the quality of recovery after c-section. All patients presenting for elective cesarean section with low transverse incision, under spinal anesthesia will be considered for inclusion.
The primary outcome will be the ObsQoR-11 score approximately 24 hours after surgery. Secondary outcomes will include the presence of nausea, vomiting or retching during surgery, the volume of intravenous fluid administered, the dose of vasopressor administered, the pain scores two hours after surgery, and the dose of opioid used in the 24 hours after surgery.
The primary analysis will be a linear regression to determine if there is a statistically significant correlation between fasting time and the ObsQoR-11 score while factoring in the variables mentioned above. Secondary analyses will determine if the fasting duration correlates with a change in any of the eleven components of the ObsQoR-11 score or the secondary outcomes listed. In addition, the fasting data will be plotted against the ObsQoR-11 score to determine if an inflection point is present.
Ten observations will be obtained for each independent variable included in the model, for a total of 100 patients in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presenting for elective c-section under spinal anesthesia
排除标准
- •Unable to communicate in French or English
- •Urgent c-section
- •Planned general anesthesia
结局指标
主要结局
Obstetric Quality of Recovery (ObsQoR-11)
时间窗: 3 months
Obstetric quality of recovery after c-section, which has been validated based on the total score of 11 questions, with total scores ranging from 0 to 110, where 0 is the worst, and 110 is the best.
次要结局
- Nausea & Vomitting(24 hours)
- Numeric Rating Scale (NRS) Pain Score 2 hours after surgery(2 hours after surgery)
研究者
Matthew Cameron, MDCM MPH
Associate Professor
Jewish General Hospital