Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery

NCT06216002 | Recruiting DMC

• 1 other identifier: 599/2566(IRB3)
• Study Type: interventional
• Target: 622
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

neuromuscular blocking agents; frailty; gynecologic oncology; surgery; anesthetic complications

Outcome Measures

Primary Outcomes (2)

• Incidence of residual neuromuscular blockade

  Incidence of residual neuromuscular blockade with the relation of frailty after gynecologic oncology surgery

  0-30 minute after surgery

• Incidence of frailty

  Incidence of frailty in patients undergoing gynecologic oncology surgery

  0 - 24 hours preoperative

Secondary Outcomes (9)

• Anesthetic technique used

  Throughout Intraoperative period, an average 3-5 hours

• Rate of blood transfusion

  Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative

• Rate of vasopressor usage

  Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative

• Length of hospital stay

  Through study completion, an average of 1 year, an average 3 - 5 days

• Rate of intensive care unit admission

  0 - 24 hours postoperative

Study Arms (1)

TOF nerve stimulation

EXPERIMENTAL

Patient receive TOF nerve stimulation in recovery room after surgery

Diagnostic Test: Train of four nerve stimulator

Interventions

Train of four nerve stimulator DIAGNOSTIC_TEST

Patient receive nerve stimulation by TOF-scan equipment at recovery room after surgery.

TOF nerve stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>,= 18 years
• Patients undergoing elective gynecologic-oncology surgery

You may not qualify if:

• Unable to communicate Thai
• Unable to understand the questionnaire
• Preexisting neuromuscular disease
• Preexisting disease involved wrist that may affect the nerve stimulator examination

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Anesthesiology department, Siriraj hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patchareya Nivatpumin, M.D.

  Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

  STUDY DIRECTOR

• Jitsupa Nithiuthai, M.D.

  Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patchareya Nivatpumin, M.D.

CONTACT

+66896662187; patchareya.niv@mahidol.ac.th

Jitsupa Nithiuthai, M.D.

CONTACT

+66661466594; jitsupa.nit@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Train of four nerve stimulation

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: January 22, 2024
• Study Start: January 2, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)