Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06216002

Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Frailty General Anesthetic Drug Adverse Reaction Gynecologic Cancer Neuromuscular Blockade Pathologic Processes Pathological Conditions, Signs and Symptoms Surgical Complication

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Anesthesiology department, Siriraj hospital, Mahidol University

Bangkok, 10700, Thailand

Location status: Recruiting

Location contact

Nutthavit Hantayapong, M.D.

CONTACT

[email protected]

+6681-925-0538

Patchareya Nivatpumin, M.D.

CONTACT

[email protected]

+662-419-7000 ext. 7990

Patchareya Nivatpumin, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Train of four nerve stimulator

Diagnostic Test

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

Primary outcomes

  1. Incidence of residual neuromuscular blockade

    Time frame: 0-30 minute after surgery

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

  2. Incidence of frailty

    Time frame: 0 - 24 hours preoperative

    Incidence of frailty in patients undergoing gynecologic oncology surgery

Secondary outcomes

  1. Anesthetic technique used

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

    Anesthetic technique used in patients undergoing gynecologic oncology surgery

  2. Rate of blood transfusion

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

    Quantity of units blood transfusion

  3. Rate of vasopressor usage

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

    Rate of vasopressor usage eg. ephedrine, norepinephrine

  4. Length of hospital stay

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

    Total number of days of hospital stay

  5. Rate of intensive care unit admission

    Time frame: 0 - 24 hours postoperative

    Number of patients who require intensive care unit admission after surgery

  6. Rate of re-intubation

    Time frame: 0 - 24 hours postoperative

    Number of patients who require re-intubation

  7. Rate of postoperative mechanical ventilation

    Time frame: 0 - 24 hours postoperative

    Number of patients who require mechanical ventilation postoperative

  8. Rate of postoperative pulmonary complications

    Time frame: 3 days after operation

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

  9. Mortality rate

    Time frame: 30 days after operation

    Number of patients who died after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Jitsupa Nithiuthai, M.D.

CONTACT

[email protected]

+66661466594

Patchareya Nivatpumin, M.D.

CONTACT

[email protected]

+66896662187

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Acronym: FIGO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2024
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.