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CompletedNCT06216002FIGOUpdated Oct 6, 2026

Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery

An interventional study of Train of four nerve stimulator in Frailty, Neuromuscular Blockade and General Anesthetic Drug Adverse Reaction, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Mahidol University · Not applicable, Interventional, and Diagnostic

Updated Oct 6, 2026Now CompletedStart date moved+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
356
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

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Conditions studied

  • Frailty
  • Neuromuscular Blockade
  • General Anesthetic Drug Adverse Reaction
  • Gynecologic Cancer
  • Surgical Complication

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Keywords

  • neuromuscular blocking agents
  • frailty
  • gynecologic oncology
  • surgery
  • anesthetic complications
03

In context

Frailty

1,199 studies on the registry are indexed under Frailty; 429 are open to participants now.

This study's enrollment of 356 is above the median of 80 across 680 interventional studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unable to communicate Thai
  • Unable to understand the questionnaire
  • Preexisting neuromuscular disease
  • Preexisting disease involved wrist that may affect the nerve stimulator examination
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
356 participants (actual)

Study arms

  • Experimental
    TOF nerve stimulation

    Patient receive TOF nerve stimulation in recovery room after surgery

    Diagnostic Test: Train of four nerve stimulator

Interventions

  • Diagnostic testTrain of four nerve stimulator

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

06

What researchers measure

Primary outcomes

  1. Incidence of residual neuromuscular blockade

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

    Time frame: 0-30 minute after surgery

  2. Incidence of frailty

    Incidence of frailty in patients undergoing gynecologic oncology surgery

    Time frame: 0 - 24 hours preoperative

Secondary outcomes

  1. Anesthetic technique used

    Anesthetic technique used in patients undergoing gynecologic oncology surgery

    Time frame: Throughout Intraoperative period, an average 3-5 hours

  2. Rate of blood transfusion

    Quantity of units blood transfusion

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

  3. Rate of vasopressor usage

    Rate of vasopressor usage eg. ephedrine, norepinephrine

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

  4. Length of hospital stay

    Total number of days of hospital stay

    Time frame: 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

    Time frame: 0 - 24 hours postoperative

  6. Rate of re-intubation

    Number of patients who require re-intubation

    Time frame: 0 - 24 hours postoperative

  7. Rate of postoperative mechanical ventilation

    Number of patients who require mechanical ventilation postoperative

    Time frame: 0 - 24 hours postoperative

  8. Rate of postoperative pulmonary complications

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

    Time frame: 3 days after operation

  9. Mortality rate

    Number of patients who died after surgery

    Time frame: 30 days after operation

07

Study locations

1 site
  • Anesthesiology department, Siriraj hospital, Mahidol University
    Bangkok, Bangkok 10700, Thailand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 6, 2026
Sites
1 site added, 1 site removed
Show site
  • Anesthesiology department, Siriraj hospital, Mahidol University · Bangkok, Thailand
Show 1 removed
  • Anesthesiology department, Siriraj hospital, Mahidol University · Bangkok, Thailand
Oct 6, 2026
Start date
Jan 2, 2024→Nov 12, 2023
Oct 6, 2026
Primary completion
Dec 31, 2025→Sep 30, 2025 (actual)
Oct 6, 2026
Enrollment
622 (estimated)→356 (actual)
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Recruiting→Completed
    1 site added, 1 site removed
    Show site
    • Anesthesiology department, Siriraj hospital, Mahidol University · Bangkok, Thailand
    Show 1 removed
    • Anesthesiology department, Siriraj hospital, Mahidol University · Bangkok, Thailand
    Start date Jan 2, 2024→Nov 12, 2023
    Primary completion Dec 31, 2025→Sep 30, 2025 (now actual)
    Enrollment 622 (estimated)→356 (actual)
    + 4 other changes: index terms, verification date, oversight details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06216002
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Jan 22, 2024
Start date
Nov 12, 2023
Primary completion
Sep 30, 2025
Completion
Dec 31, 2025
Last update
Oct 6, 2026

Study contacts

Patchareya Nivatpumin, M.D.
study director · Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
Jitsupa Nithiuthai, M.D.
principal investigator · Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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