Comparative Analysis of Spinal Anesthesia Versus General Anesthesia for vNOTES

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT05688943
Status
Enrolling By Invitation

Conditions

  • Anesthesia
  • Tubal Ligation

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
Jun 2025
Primary completion
Jul 15, 2026
Completion
Jul 15, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: General Anesthesia
    This arm will receive general anesthesia for vNOTES surgery.
  • Experimental: Spinal Anesthesia
    This arm will receive spinal anesthesia for vNOTES surgery.

Primary Outcome Measure

Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia [ Time Frame: during surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160-

Find similar trials in Kansas City, KS

By research site
University of Kansas Medical Center· Kansas City, KS

Related Studies