NCT05688943

Comparative Analysis of Spinal Anesthesia Versus General Anesthesia for vNOTES

Enrolling by Invitation
NAAges 21+Interventional
University of Kansas Medical Center
~20 participants
Updated 2025-06-05 on ClinicalTrials.gov
What's tested:Spinal AnesthesiaGeneral Anesthesia

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia
Measured over during surgery
+1 more outcome measured
Anesthesia
Tubal Ligation
1 sites across 1 states
Kansas1
  • Meredith K Gray, MD · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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.

Exclusion

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.
  • Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesiaduring 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 intraoperative complications.

  • Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesiaup 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.