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Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery (FIGO)

M

Mahidol University

Status

Enrolling

Conditions

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

Treatments

Diagnostic Test: Train of four nerve stimulator

Study type

Interventional

Funder types

Other

Identifiers

NCT06216002
599/2566(IRB3)

Details and patient eligibility

About

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.

Full 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.

Enrollment

622 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

622 participants in 1 patient group

TOF nerve stimulation
Experimental group
Description:
Patient receive TOF nerve stimulation in recovery room after surgery
Treatment:
Diagnostic Test: Train of four nerve stimulator

Trial contacts and locations

1

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Central trial contact

Jitsupa Nithiuthai, M.D.; Patchareya Nivatpumin, M.D.

Data sourced from clinicaltrials.gov

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