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

May 7, 2025 updated by: Mahidol University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

622

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Anesthesiology department, Siriraj hospital, Mahidol University
        • Principal Investigator:
          • Patchareya Nivatpumin, M.D.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TOF nerve stimulation
Patient receive TOF nerve stimulation in recovery room after surgery
Diagnostic test: Train of four nerve stimulator
Patient receive nerve stimulation by TOF-scan equipment at recovery room after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of residual neuromuscular blockade
Time Frame: 0-30 minute after surgery
Incidence of residual neuromuscular blockade with the relation of frailty after gynecologic oncology surgery
0-30 minute after surgery
Incidence of frailty
Time Frame: 0 - 24 hours preoperative
Incidence of frailty in patients undergoing gynecologic oncology surgery
0 - 24 hours preoperative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Study Director: Patchareya Nivatpumin, M.D., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
  • Principal Investigator: Jitsupa Nithiuthai, M.D., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 599/2566(IRB3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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