Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Quality of Recovery Score Post Operative at 24 Hours
研究概览
简要总结
Hypothesis: The intraoperative administration of ketamine will result in a 30% reduction in opiate requirement following endometrial ablation surgery and the intraoperative administration of ketamine will result in a decreased time to meet discharge criteria in the PACU following endometrial ablation surgery.
The research question is "Does intraoperative administration of ketamine result in decreased postoperative opiate requirement and time to discharge from the postanesthesia recovery unit (PACU) following hysteroscopic endometrial ablation".
详细描述
Preoperatively:
Subjects will be recruited up to 21days prior to the day of surgery. After informed consent is obtained, subjects will be randomly assigned to one of two groups:
Group A: Saline group Group B: 1% Ketamine group
A verbal rating scale (VRS) will be used to assess pain preoperatively. The patient will be asked to identify the severity of pain by indicating on a scale of 0-10 where 0 is "no pain" and 10 is "the worst pain imaginable".
Baseline Quality of Recovery will be obtained. (Appendix F)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gender: Female
- •Age: 18-65 years
- •Non-pregnant, non-lactating
- •Surgery: Outpatient hysteroscopic Novasure® endometrial ablation
- •Language: English speaking
- •Consent: Obtained
排除标准
- •Patient refusal
- •Under 18 or over age 65
- •Non-English Speaking
- •Pregnancy, Breast feeding
- •Hysteroscopic procedures using Thermachoice® ablation device
- •Chronic use or addiction to opiates, sedatives, non-opiate analgesics
- •History of heavy alcohol usage (>4 drinks/day)
- •Significant cardiovascular or pulmonary disease
- •Psychiatric or emotional disorder
- •Allergy to anesthetic agents utilized in the protocol
- •Thyrotoxicosis
结局指标
主要结局
Quality of Recovery Score Post Operative at 24 Hours
时间窗: 24 hours post operative
Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery.
次要结局
未报告次要终点
研究者
Shireen Ahmad
Principal Investigator
Northwestern University