Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery

NCT ID: NCT06216002

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

622 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Train of four nerve stimulation
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TOF nerve stimulation

Patient receive TOF nerve stimulation in recovery room after surgery

Group Type EXPERIMENTAL

Train of four nerve stimulator

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Train of four nerve stimulator

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patchareya Nivatpumin, M.D.

Role: STUDY_DIRECTOR

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

Jitsupa Nithiuthai, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Anesthesiology department, Siriraj hospital, Mahidol University

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Patchareya Nivatpumin, M.D.

Role: CONTACT

+66896662187

Jitsupa Nithiuthai, M.D.

Role: CONTACT

+66661466594

Facility Contacts

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Patchareya Nivatpumin, M.D.

Role: primary

+662-419-7000 ext. 7990

Nutthavit Hantayapong, M.D.

Role: backup

+6681-925-0538

Other Identifiers

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599/2566(IRB3)

Identifier Type: -

Identifier Source: org_study_id

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