Comparative Analysis of Spinal Anesthesia Versus General Anesthesia for vNOTES

NCT05688943 | Enrolling By Invitation DMC

• 1 other identifier: STUDY00149365
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Tubal Ligation

Keywords

vNOTES; Tubal Sterilization; Regional Anesthesia; laparoscopy

Outcome Measures

Primary Outcomes (2)

• Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia

  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.

  during surgery

• Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia

  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.

  up to 7 days after surgery

Secondary Outcomes (3)

• 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

Study Arms (2)

General Anesthesia

ACTIVE COMPARATOR

This arm will receive general anesthesia for vNOTES surgery.

Procedure: General Anesthesia

Spinal Anesthesia

EXPERIMENTAL

This arm will receive spinal anesthesia for vNOTES surgery.

Procedure: Spinal Anesthesia

Interventions

Spinal Anesthesia PROCEDURE

Fentanyl (1µg/kg) and midazolam are administered intravenously prior to puncture. Using an aseptic technique, the subarachnoid space is punctured with a 25/27 gauge needle in the intervertebral space, and a standard dose of chloroprocaine 45-60mg is injected. Alternative spinal anesthetics include bupivacaine 6-15mg and mepivacaine 50-70mg. The participant is then placed in the supine position in 10-degree Trendelenburg until the lack of sensitivity is adequate at spinal level T4.

Also known as: Regional Anesthesia

Spinal Anesthesia

General Anesthesia PROCEDURE

General anesthesia is a state of controlled unconsciousness. During a general anesthetic, medicines are used to send the participant to sleep making the participant unaware of surgery and so that the participant does not move or feel pain while the surgery is carried out. Induction of general anesthesia includes the use intravenous sedative-hypnotic agents such as propofol, etomidate, or ketamine, along with adjuvant agents such as fentanyl, lidocaine, or midazolam. A neuromuscular blocking agent such as succinylcholine or rocuronium is used to facilitate endotracheal intubation.

Also known as: Endotracheal intubation

General Anesthesia

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: cis-female or gender non-conforming person
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Interventions

Anesthesia, Spinal; Anesthesia, Conduction; Anesthesia, General; Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Meredith K Gray, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Obstetrics & Gynecology

Model Details: This a a randomized control trail that will have 2 groups. One will be the control group and will receive the standard of care, general anesthesia. The other group will be the experimental group which will receive spinal anesthesia in place in general anesthesia.

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 18, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (1)