Comparative Analysis of Spinal Versus General Anesthesia for Vaginal Natural Orifice Transluminal Endoscopic Tubal Sterilization: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia
研究概览
简要总结
This study compares general anesthesia and spinal anesthesia for vNOTE tubal sterilization. A direct comparison of these methods has not been done before for this surgical approach. Investigators will aim to compare the two methods to determine the differences in perioperative complications, postoperative pain, postoperative nausea and vomiting, and the time to get the patient ready for discharge from the recovery room.
详细描述
Anesthesia is a controlled, temporary loss of sensation or awareness used to perform surgical procedures. Spinal anesthesia is commonly used in obstetrics and gynecology for vaginal procedures as well as cesarean sections. The use of spinal anesthesia for laparoscopic surgery is an adequate and safe alternative to general anesthesia which remains the gold standard. Vaginal Natural Orifice Endoscopic Surgery (vNOTES) is a minimally invasive laparoscopic approach used for tubal sterilization that is currently performed under general anesthesia. This study is proposing that spinal anesthesia is an adequate and safe alternative to general anesthesia for vNOTES tubal sterilization. If participants join the study, all other routine care will continue but the researchers will randomly assign participants, like flipping a coin, to one of two groups. Both types of anesthesia are commonly used but the researchers are doing this study because it is not known if spinal anesthesia is a better alternative than general anesthesia which is typically used. The goal is to find out what might be best for future patients. If it turns out the two types of anesthesia are about the same, then surgeons would know that choosing the type with fewer side effects still gives satisfactory results and allows for this surgery to be performed safely. The risks involved in participating in this study are the same as all other anesthetic and surgical procedures which have significant physical risks. If participants choose to enroll, there will be a 50/50 chance of being assigned to either the standard of care group which will receive general anesthesia or the experimental group which will receive spinal anesthesia. Benefits cannot be guaranteed but, It is possible participants could be assigned to a type of anesthesia that has fewer side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥21years old keeping in line with regulations posed by federally funded insurance programs
- •cis-female or gender non-conforming person with female reproductive organs
- •request for permanent sterilization
- •no prior hysterectomy or trachelectomy
- •undergoing tubal sterilization only or salpingo-oophorectomy only for cancer risk reduction due to genetic pre-disposition
- •non-emergent/scheduled outpatient procedure
- •non-pregnant, ≥6 weeks postpartum
- •American Society of Anesthesia (ASA) physical status classification I or II
- •All subjects must be determined to be appropriate candidates for VNOTES by the surgeon based on the review of medical and surgical history
- •Those undergoing additional procedures such as insertion or removal of a long-acting reversible contraceptive (Intrauterine device or subdermal implant) may be included.
排除标准
- •Ectopic pregnancy, ovarian torsion, or adnexal mass requiring urgent or emergent treatment;
- •Trans-masculine person considering surgical masculinization due to additional surgeries involved;
- •Undergoing adnexal surgery for suspected or confirmed malignancy;
- •History of endometriosis, or other inflammatory diseases that have been determined to add to the complexity and increase the risk of injury with vaginal surgery;
- •prior genital surgery or congenital abnormality that would prevent vaginal access;
- •prior spinal surgery or severe scoliosis that would hinder placement and effective functioning of neuraxial anesthetics;
- •uncorrected thrombocytopenia or coagulopathy;
- •ASA physical status classification ≥III.
结局指标
主要结局
Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia
时间窗: up to 7 days after surgery
This study seeks to explore the feasibility of performing vaginal natural orifice transluminal endoscopic surgery (VNOTES) tubal sterilization under small-dose spinal anesthesia compared to the gold standard, general anesthesia, in healthy patients and to analyze postoperative complications.
次要结局
- Rate of post-operative pain between patients(immediately after the surgery)
- Occurrence of postoperative nausea/vomiting(immediately after the surgery)
- Compare time until PACU discharge-to-home readiness between patients(immediately after the surgery)
研究者
Meredith Gray
Associate Professor, Obstetrics & Gynecology
University of Kansas Medical Center