Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery

Not Applicable

Recruiting

• Conditions: Neuromuscular Blockade; General Anesthetic Drug Adverse Reaction; Gynecologic Cancer; Surgical Complication; Frailty
• Interventions: Diagnostic Test: Train of four nerve stimulator

• Registration Number: NCT06216002
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2023-11-13
• Study Start: 2024-01-02
• Study First Submitted QC: 2024-01-10
• Study First Posted: 2024-01-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 622

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TOF nerve stimulation	Train of four nerve stimulator	Patient receive TOF nerve stimulation in recovery room after surgery

Primary Outcome Measures

Name	Time	Method
Incidence of residual neuromuscular blockade	0-30 minute after surgery	Incidence of residual neuromuscular blockade with the relation of frailty after gynecologic oncology surgery
Incidence of frailty	0 - 24 hours preoperative	Incidence of frailty in patients undergoing gynecologic oncology surgery

Secondary Outcome Measures

Name	Time	Method
Anesthetic technique used	Throughout Intraoperative period, an average 3-5 hours	Anesthetic technique used in patients undergoing gynecologic oncology surgery
Rate of blood transfusion	Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative	Quantity of units blood transfusion
Rate of vasopressor usage	Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative	Rate of vasopressor usage eg. ephedrine, norepinephrine
Length of hospital stay	Through study completion, an average of 1 year, an average 3 - 5 days	Total number of days of hospital stay
Mortality rate	30 days after operation	Number of patients who died after surgery
Rate of intensive care unit admission	0 - 24 hours postoperative	Number of patients who require intensive care unit admission after surgery
Rate of re-intubation	0 - 24 hours postoperative	Number of patients who require re-intubation
Rate of postoperative mechanical ventilation	0 - 24 hours postoperative	Number of patients who require mechanical ventilation postoperative
Rate of postoperative pulmonary complications	3 days after operation	Number of patients who have postoperative pulmonary complications eg. prolonged intubation, atelectasis, pneumonia etc.

Trial Locations

Locations (1)

Anesthesiology department, Siriraj hospital, Mahidol University; 🇹🇭 Bangkok, Thailand