AnesthesiaNCT05688943
Comparative Analysis of Spinal Anesthesia Versus General Anesthesia for vNOTES
A study testing Spinal Anesthesia and General Anesthesia in people with Anesthesia and Tubal Ligation, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Tubal Ligation
- What is being tested?
- Spinal Anesthesia and General Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 22 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Comparative Analysis of Spinal Versus General Anesthesia for Vaginal Natural Orifice Transluminal Endoscopic Tubal Sterilization: A Prospective, Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Anesthesia, Tubal Ligation
- Being tested
- Spinal Anesthesia, General Anesthesia
- Keywords
- vNOTES, Tubal Sterilization, Regional Anesthesia, laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal AnesthesiaProcedure or surgery
Also called Regional Anesthesia
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 AnesthesiaProcedure or surgery
Also called Endotracheal intubation
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 group | Role | What they receive |
|---|---|---|
| General Anesthesia | Active comparator | This arm will receive general anesthesia for vNOTES surgery. Receives: Procedure: General Anesthesia |
| Spinal Anesthesia | Experimental | This arm will receive spinal anesthesia for vNOTES surgery. Receives: Procedure: Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 7 days after surgery
Secondary outcomes (3)
Rate of Post-operative Pain Between Patients
To determine the differences in postoperative pain between patients in each anesthesia group based on a pain scale assessed post-operatively.
Measured: immediately after the surgery
Occurrence of Postoperative Nausea/Vomiting
To determine the differences in the occurrence of postoperative nausea/vomiting (PONV) in a yes or no survey question.
Measured: immediately after the surgery
Compare Time Until PACU Discharge-to-home Readiness Between Patients
To determine the differences in time until post-anesthesia care unit (PACU) discharge-to-home readiness between patients postoperatively.
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Mar 2023
- Primary completion22 Aug 2025
- Study completion22 Aug 2025
Why it stopped: Recruitment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meredith Gray, University of Kansas Medical Center
- Investigators
- Meredith K Gray, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688943
- Sponsor's protocol ID
- STUDY00149365
- Status last verified
- Jul 2026
- First submitted
- 14 Dec 2022
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Spinal Versus General Anesthesia for Vaginal Natural Orifice Transluminal Endoscopic Tubal Sterilization: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05688943
- Acronym / sponsor ID
- STUDY00149365
- Conditions
- Anesthesia, Tubal Ligation
- Keywords
- vNOTES, Tubal Sterilization, Regional Anesthesia, laparoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Active comparator | Procedure: General AnesthesiaThis arm will receive general anesthesia for vNOTES surgery. |
| Spinal Anesthesia | Experimental | Procedure: Spinal AnesthesiaThis arm will receive spinal anesthesia for vNOTES surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal AnesthesiaAlso: Regional AnesthesiaFentanyl (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. | Procedure or surgery | Spinal Anesthesia |
| General AnesthesiaAlso: Endotracheal intubationGeneral 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. | Procedure or surgery | General Anesthesia |
Primary outcome
Incidence of Perioperative Complications Performing VNOTES Tubal Sterilization With Spinal Anesthesia
Time frame: during 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 Anesthesia
Time frame: 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.
3 secondary outcomes
Rate of Post-operative Pain Between Patients
Time frame: immediately after the surgery
Occurrence of Postoperative Nausea/Vomiting
Time frame: immediately after the surgery
Compare Time Until PACU Discharge-to-home Readiness Between Patients
Time frame: immediately after the surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meredith K Gray, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Anesthesia and General Anesthesia in people with Anesthesia and Tubal Ligation, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Perioperative Complications Performing VNOTES Tubal Sterilization With Spinal Anesthesia (time frame: during surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.