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Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06216002
Acronym
FIGO
Enrollment
622
Registered
2024-01-22
Start date
2024-01-02
Completion date
2025-12-31
Last updated
2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

neuromuscular blocking agents, frailty, gynecologic oncology, surgery, anesthetic complications

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTTrain of four nerve stimulator

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

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Train of four nerve stimulation

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of residual neuromuscular blockade0-30 minute after surgeryIncidence of residual neuromuscular blockade with the relation of frailty after gynecologic oncology surgery
Incidence of frailty0 - 24 hours preoperativeIncidence of frailty in patients undergoing gynecologic oncology surgery

Secondary

MeasureTime frameDescription
Rate of vasopressor usageThroughout Intraoperative period, an average 3-5 hours to 24 hours postoperativeRate of vasopressor usage eg. ephedrine, norepinephrine
Length of hospital stayThrough study completion, an average of 1 year, an average 3 - 5 daysTotal number of days of hospital stay
Rate of intensive care unit admission0 - 24 hours postoperativeNumber of patients who require intensive care unit admission after surgery
Anesthetic technique usedThroughout Intraoperative period, an average 3-5 hoursAnesthetic technique used in patients undergoing gynecologic oncology surgery
Rate of postoperative mechanical ventilation0 - 24 hours postoperativeNumber of patients who require mechanical ventilation postoperative
Rate of postoperative pulmonary complications3 days after operationNumber of patients who have postoperative pulmonary complications eg. prolonged intubation, atelectasis, pneumonia etc.
Mortality rate30 days after operationNumber of patients who died after surgery
Rate of re-intubation0 - 24 hours postoperativeNumber of patients who require re-intubation
Rate of blood transfusionThroughout Intraoperative period, an average 3-5 hours to 24 hours postoperativeQuantity of units blood transfusion

Countries

Thailand

Contacts

Primary ContactPatchareya Nivatpumin, M.D.
patchareya.niv@mahidol.ac.th+66896662187
Backup ContactJitsupa Nithiuthai, M.D.
jitsupa.nit@mahidol.ac.th+66661466594

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026