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临床试验/NCT01890707
NCT01890707终止不适用

A Comparison of the Effect of Intravenous Sedation Versus General Anesthesia in Patients Undergoing Minor Gynecologic Surgery

Northwestern University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2012年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
19
试验地点
2
主要终点
Quality of Recovery - 40 Scores

研究概览

简要总结

The use of deep sedation may improve the quality of recovery of patients undergoing minor gynecologic procedures. These patients may also have shorter hospital stays and potentially lower healthcare costs. Additionally, the use of deep sedation for second trimester pregnancy termination may be associated with less bleeding, a smaller decrease in perioperative hemoglobin and better quality of recovery.

详细描述

Once consent for the study has been obtained subjects will be randomly allocated into 2 groups, using a computer generated table of random numbers. Anesthetic management will be standardized (Appendix 1, 2). Group A (study group) will receive deep sedation . Group B (control group) will receive general anesthesia. Subjects will be instructed preoperatively, on the proper use of the verbal rating scale (VRS) for pain and nausea scores. All patients routinely have a blood count checked preoperatively and based on the results are either screened for cross matched for potential transfusion. All subjects will complete the POMS questionnaire preoperatively.

Gestational size will be determined by the surgeon preoperatively using the most recent ultrasound measurements.

Participants will undergo a standard pre-operative evaluation, laboratory testing and laminaria insertion one day prior to surgery in the Family Planning and Contraception Clinic. All subjects will receive a prescription for ibuprofen 600mg and hydrocodone/acetaminophen 5/325mg with standardized instructions to take the last oral dose no later than six hours before the operative time. The last dose medication and time of administration will be recorded.

Intraoperative management:

A standardized intraoperative anesthetic protocol will be utilized by the anesthesia personnel (Appendix #1, 2).Clinical management of excessive intraoperative bleeding will be at the discretion of the anesthesiologist.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients undergoing second trimester abortions:
  • Pregnancy: 12-24 weeks gestational size
  • ASA PS I and II
  • No history of diabetes mellitus, GERD or sleep apnea
  • Age: > 18 years of age
  • Fluent in English

排除标准

  • ASA PSIII, Emergency surgery
  • Pregnancy: > 24 weeks gestational size
  • Age: < 18 years of age
  • Diabetes mellitus
  • Gastroesophageal reflux disease
  • Hiatal hernia
  • Obstructive sleep apnea
  • Coagulopathy
  • Chronic pain syndromes
  • Chronic opioid dependency
  • Alcohol or illicit drug abuse
  • BMI: > 35Kg/m2
  • Allergy to study protocol drugs
  • Drop out criteria:
  • Subjects withdrawal of consent.
  • Subjects who experience massive bleeding intraoperatively, will be excluded from the final data analysis

结局指标

主要结局

Quality of Recovery - 40 Scores

时间窗: 24 hours

The patients self reported quality of recovery - 40 scores as completed 24 hours after the surgical procedure. 40 questions regarding the recovery of patients on a 1 poor-5 excellent scale. Total score on scale 40 (poor recovery)-200 (excellent recovery)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shireen Ahmad

Principal Investigator

Northwestern University

研究点 (2)

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