The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium

December 14, 2015 updated by: Konkuk University Medical Center

The Comparison of Sugammadex and Conventional Cholinesterase Inhibitor on the Aspect of Postoperative Delirium in the Elderly Patients Undergoing Hip Surgery

This study evaluated the effect of sugammadex on postoperative delirium in elderly patients undergoing hip fracture surgery.

Medical records from 235 consecutive patients undergoing hip fracture surgery were retrospectively reviewed and total 61 patients were excluded for age under 60 years, preoperative neurologic problem. Finally total 174 patients aged over 60 years undergoing hip fracture surgery with general anaesthesia using a neuromuscular blocking agent from 2012 to 2014 at a university hospital were analyzed to compare perioperative incidence of postoperative delirium, pulmonary complications, intensive care unit (ICU) admission, and ICU and hospital stay duration and laboratory findings between patients treated with sugammadex (S group) and conventional cholinesterase inhibitors (C group).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study population The medical records of patients undergoing hip surgery under general anaesthesia with neuromuscular blocking agents at Konkuk University Medical Center from February 2012 to August 2014 review.

The patients were divided according to use (S group) or not (C group) of sugammadex for recovery from neuromuscular blocking agent.

exclusion criteria

  1. age < 60 years
  2. preoperative neurologic or psychological problem including dementia, Parkinson's disease or delirium
  3. other concurrent surgery.

Assessment of postoperative delirium Evaluation of postoperative delirium was done in the general ward or in the ICU by the responsible surgeon using commonly accepted delirium symptoms in addition to the confusion assessment method (CAM) rating for delirium. Delirium symptoms were defined as the presence of any of the following: acute onset and fluctuating symptoms; inattention; speech disorganization; level of consciousness change; disorientation; memory impairment; perceptual disturbance; abnormal psychomotor activity; and altered sleep wake cycle. Incidence of postoperative delirium assess by medical records review.

Postoperative clinical follow-up

By medical records review, the following clinical data were obtained:

transfusion amount of packed red blood cell during intraoperative period and up to postoperative 24 hours postoperative visual analogue scale (VAS, ranging from 0 [no pain] to 100 [worst pain imaginable]) up to postoperative day 1; delayed extubation events up to postoperative day 7; postoperative pulmonary complication [new onset abnormal findings in postoperative chest radiography with pulmonary symptoms such as cough, sputum, dyspnea] up to postoperative day 7; postoperative hypoxia [oxygen saturation on pulse oximeter < 95%] up to postoperative 24 hours; the event of admission to ICU; duration of ICU stay; duration of hospital stay. Perioperative laboratory findings, Haemoglobin (Hb), haematocrit (Hct), and serum levels of total protein, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine and high sensitivity C reactive protein (HS-CRP) during intraoperative period and up to postoperative 24 hours were assessed by medical records review.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Seong-Hyop Kim, M.D., Ph.D.
  • Phone Number: 82-2-2030-5454
  • Email: yshkim75@daum.net

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 143-729
        • Recruiting
        • Konkuk University Medical Center
        • Contact:
          • Seoung-Hyop Kim, M.D,Ph.D
          • Phone Number: 82-2-2030-5454
          • Email: yshkim@daum.net
        • Principal Investigator:
          • Seong-Hyop Kim, M.D,Ph.D

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing hip surgery under general anaesthesia with neuromuscular blocking agents

Description

Inclusion Criteria:

Patients undergoing hip surgery under general anaesthesia with neuromuscular blocking agents

Exclusion Criteria:

  1. age < 60 years
  2. preoperative neurologic or psychological problem including dementia, Parkinson's disease or delirium
  3. other concurrent surgery.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of postoperative delirium
Time Frame: up to postoperative 7 days
up to postoperative 7 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Konkuk University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seong-Hyop Kim, M.D., Ph.D., Konkuk University Medical Center

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KUH1160075

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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