Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery

Frailty Clinical Trial

— FIGO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06216002
• Other study ID #: 599/2566(IRB3)
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: Mahidol University
• Contact: Patchareya Nivatpumin, M.D.
• Phone: +66896662187
• Email: patchareya.niv[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 622
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Drug-Related Side Effects and Adverse Reactions
• Frailty
• General Anesthetic Drug Adverse Reaction
• Gynecologic Cancer
• Neuromuscular Blockade
• Surgical Complication

Intervention

Diagnostic Test:
• Train of four nerve stimulator
Patient receive nerve stimulation by TOF-scan equipment at recovery room after surgery.

Locations

Country	Name	City	State
Thailand	Anesthesiology department, Siriraj hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of residual neuromuscular blockade	Incidence of residual neuromuscular blockade with the relation of frailty after gynecologic oncology surgery	0-30 minute after surgery
Primary	Incidence of frailty	Incidence of frailty in patients undergoing gynecologic oncology surgery	0 - 24 hours preoperative
Secondary	Anesthetic technique used	Anesthetic technique used in patients undergoing gynecologic oncology surgery	Throughout Intraoperative period, an average 3-5 hours
Secondary	Rate of blood transfusion	Quantity of units blood transfusion	Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative
Secondary	Rate of vasopressor usage	Rate of vasopressor usage eg. ephedrine, norepinephrine	Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative
Secondary	Length of hospital stay	Total number of days of hospital stay	Through study completion, an average of 1 year, an average 3 - 5 days
Secondary	Rate of intensive care unit admission	Number of patients who require intensive care unit admission after surgery	0 - 24 hours postoperative
Secondary	Rate of re-intubation	Number of patients who require re-intubation	0 - 24 hours postoperative
Secondary	Rate of postoperative mechanical ventilation	Number of patients who require mechanical ventilation postoperative	0 - 24 hours postoperative
Secondary	Rate of postoperative pulmonary complications	Number of patients who have postoperative pulmonary complications eg. prolonged intubation, atelectasis, pneumonia etc.	3 days after operation
Secondary	Mortality rate	Number of patients who died after surgery	30 days after operation