Clinical trial NCT06216002: Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery
Official title: Incidence of Residual Neuromuscular Blockade in Patients With Frailty Undergoing Gynecologic Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Neuromuscular Blockade
General Anesthetic Drug Adverse Reaction
Gynecologic Cancer
Surgical Complication
Keywords: neuromuscular blocking agents
frailty
gynecologic oncology
surgery
anesthetic complications
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 622
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Train of four nerve stimulation
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Incidence of residual neuromuscular blockade
timeFrame: 0-30 minute after surgery
measure: Incidence of frailty
timeFrame: 0 - 24 hours preoperative
Secondary outcomes:
measure: Anesthetic technique used
timeFrame: Throughout Intraoperative period, an average 3-5 hours
measure: Rate of blood transfusion
timeFrame: Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative
measure: Rate of vasopressor usage
timeFrame: Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative
measure: Length of hospital stay
timeFrame: Through study completion, an average of 1 year, an average 3 - 5 days
measure: Rate of intensive care unit admission
timeFrame: 0 - 24 hours postoperative
measure: Rate of re-intubation
timeFrame: 0 - 24 hours postoperative
measure: Rate of postoperative mechanical ventilation
timeFrame: 0 - 24 hours postoperative
measure: Rate of postoperative pulmonary complications
timeFrame: 3 days after operation
measure: Mortality rate
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Anesthesiology department, Siriraj hospital, Mahidol University
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Patchareya Nivatpumin, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Jitsupa Nithiuthai, M.D.
role: PRINCIPAL_INVESTIGATOR
References: