NCT05051371

Brief Summary

In this study, we aimed to determine the knowledge levels and approaches of anesthesiologists working in our clinic about postoperative residual curarization(PORC) in elderly patients with a questionnaire. In addition, we aimed to determine the incidence of PORC and factors associated with PORC in the recovery unit in elderly patients over 65 years of age who underwent surgery under general anesthesia using muscle relaxants with a prospective observational study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

August 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

August 2, 2021

Last Update Submit

September 10, 2021

Conditions

Keywords

Postoperative residual curarizationGeriatricsTrain of four

Outcome Measures

Primary Outcomes (1)

  • The incidence of postoperative residual curarization

    The incidence of elderly patients that Train of Four(TOF) rate \<0.9 in the postoperative care unit

    through study completion( anticipated 5 months)

Interventions

Train of four monitoring in postoperative care unit

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Electively operated elderly patients \>65 years old under general anesthesia

You may qualify if:

  • age \>65
  • general anesthesia using non-depolarizing neuromuscular blocker

You may not qualify if:

  • Patients with an ASA score greater than 3
  • Those with contraindications to anesthetic drugs
  • Those with neuromuscular, neurological and psychiatric diseases
  • Patients in whom TOF monitoring is not possible in the ulnar nerve region
  • Patients with advanced renal failure
  • Patients with advanced hepatic insufficiency
  • Those with decompensated heart failure
  • Patients with BMI\<18 and BMI\>30
  • Patients with uncontrolled hypertension, uncontrolled diabetes, pheochromocytoma, thyroid dysfunction
  • Those who are incapable of reading and signing the consent form
  • Patients who do not want to sign the consent form
  • Patients deemed unsuitable by the investigator
  • Those with chronic opioid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Neuromuscular Monitoring

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Aysun Postaci

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. Dr. Nadide Aysun Postaci

Study Record Dates

First Submitted

August 2, 2021

First Posted

September 21, 2021

Study Start

August 15, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations