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Recruiting NCT06216002

Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery

No phase Interventional Frailty Neuromuscular Blockade General Anesthetic Drug Adverse Reaction Gynecologic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Train of four nerve stimulator.
Who it may be relevant to
Registry conditions: Frailty, Neuromuscular Blockade, General Anesthetic Drug Adverse Reaction, Gynecologic Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 test Train of four nerve stimulator
    Patient receive nerve stimulation by TOF-scan equipment at recovery room after surgery.

Primary outcome measures

  • Incidence of residual neuromuscular blockade [Time frame: 0-30 minute after surgery]
  • Incidence of frailty [Time frame: 0 - 24 hours preoperative]
Secondary outcome measures (9)
  • Anesthetic technique used [Time frame: Throughout Intraoperative period, an average 3-5 hours]
  • Rate of blood transfusion [Time frame: Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative]
  • Rate of vasopressor usage [Time frame: Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative]
  • Length of hospital stay [Time frame: Through study completion, an average of 1 year, an average 3 - 5 days]
  • Rate of intensive care unit admission [Time frame: 0 - 24 hours postoperative]
  • Rate of re-intubation [Time frame: 0 - 24 hours postoperative]
  • Rate of postoperative mechanical ventilation [Time frame: 0 - 24 hours postoperative]
  • Rate of postoperative pulmonary complications [Time frame: 3 days after operation]
  • Mortality rate [Time frame: 30 days after operation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Thailand · 1 center
  • Anesthesiology department, Siriraj hospital, Mahidol University — Bangkok

Identifiers

NCT: NCT06216002 · 599/2566(IRB3)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗