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FrailtyFIGONCT06216002

Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery

A study testing Train of four nerve stimulator in people with Frailty and Neuromuscular Blockade, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Frailty among patients undergoing surgery is strongly associated with an elevated risk of adverse perioperative outcomes, heightened incidence of postoperative complications, increased mortality rates, and prolonged hospital length of stay. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Train of four nerve stimulator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
356 participants
Where
1 siteThailand
Study dates
12 Nov 2023to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >,= 18 years
  • Patients undergoing elective gynecologic-oncology surgery

Who cannot join

  • Unable to communicate Thai
  • Unable to understand the questionnaire
  • Preexisting neuromuscular disease
  • Preexisting disease involved wrist that may affect the nerve stimulator examination

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Anesthesiology department, Siriraj hospital, Mahidol University

    Bangkok, Bangkok, 10700

Other trials in Thailand

About this study

Official title: Incidence of Residual Neuromuscular Blockade in Patients With Frailty Undergoing Gynecologic Cancer Surgery

Frailty among patients undergoing surgery is strongly associated with an elevated risk of adverse perioperative outcomes, heightened incidence of postoperative complications, increased mortality rates, and prolonged hospital length of stay. Our focus centers on investigating the frailty index in the context of complications experienced by patients undergoing oncologic gynecology surgery. The principal objective of this research is to elucidate the extent to which residual neuromuscular blocking agents are linked to frailty.

Read the detailed description

Among patients undergoing oncologic gynecological procedures, such as those for vulvar cancer, endometrial cancer, and ovarian cancer, the incidence of frailty has been observed to range from 14% to 45%. Frailty directly influences the metabolism of anesthetic agents and intraoperative management. Furthermore, the prevalence of residual neuromuscular blocking agents following surgery can be as high as 26% to 53%. No prior research has investigated the correlation between residual muscle relaxants and frailty in gynecologic oncology patients. This study is designed to assess the prevalence of residual muscle relaxants in these patients with frailty. Additionally, data on the incidence of frailty and its impact on postoperative outcomes and prognosis in patients undergoing gynecologic oncology surgery will be collected and reported.

Being tested
Train of four nerve stimulator
Keywords
neuromuscular blocking agents, frailty, gynecologic oncology, surgery, anesthetic complications
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Train of four nerve stimulatorDiagnostic test

    Patient receive nerve stimulation by TOF-scan equipment at recovery room after surgery.

Study groups in NCT06216002
Study groupRoleWhat they receive
TOF nerve stimulationExperimentalPatient receive TOF nerve stimulation in recovery room after surgery
Receives: Diagnostic Test: Train of four nerve stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of residual neuromuscular blockade

    Incidence of residual neuromuscular blockade with the relation of frailty after gynecologic oncology surgery

    Measured: 0-30 minute after surgery

  2. Incidence of frailty

    Incidence of frailty in patients undergoing gynecologic oncology surgery

    Measured: 0 - 24 hours preoperative

Secondary outcomes (9)

  1. Anesthetic technique used

    Anesthetic technique used in patients undergoing gynecologic oncology surgery

    Measured: Throughout Intraoperative period, an average 3-5 hours

  2. Rate of blood transfusion

    Quantity of units blood transfusion

    Measured: Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative

  3. Rate of vasopressor usage

    Rate of vasopressor usage eg. ephedrine, norepinephrine

    Measured: Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative

  4. Length of hospital stay

    Total number of days of hospital stay

    Measured: Through study completion, an average of 1 year, an average 3 - 5 days

  5. Rate of intensive care unit admission

    Number of patients who require intensive care unit admission after surgery

    Measured: 0 - 24 hours postoperative

  6. Rate of re-intubation

    Number of patients who require re-intubation

    Measured: 0 - 24 hours postoperative

  7. Rate of postoperative mechanical ventilation

    Number of patients who require mechanical ventilation postoperative

    Measured: 0 - 24 hours postoperative

  8. Rate of postoperative pulmonary complications

    Number of patients who have postoperative pulmonary complications eg. prolonged intubation, atelectasis, pneumonia etc.

    Measured: 3 days after operation

  9. Mortality rate

    Number of patients who died after surgery

    Measured: 30 days after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start12 Nov 2023
  3. Primary completion30 Sep 2025
  4. Study completion31 Dec 2025

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Train of four nerve stimulation
Masking
None (open label)
Enrolment
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06216002
Sponsor's protocol ID
599/2566(IRB3)
Acronym
FIGO
Status last verified
Oct 2026
First submitted
13 Nov 2023
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Train of four nerve stimulator in people with Frailty and Neuromuscular Blockade, run by Mahidol University at 1 site in Thailand.

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 2 inclusion and 4 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: finished, as of the sponsor's last update on 6 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 Thailand. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 residual neuromuscular blockade (time frame: 0-30 minute after 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?

On the ClinicalTrials.gov record for NCT06216002.

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 6 Oct 2026.

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