Risk Factors of Recovery Room Delirium After Elective Non-cardiovascular Surgery

July 20, 2020 updated by: Wei Mei, Huazhong University of Science and Technology

Risk Factors of Recovery Room Delirium After Elective Non-cardiovascular Surgery in Post-anaesthesia Care Unit

Despite recent advances in postoperative delirium research, the proportion of patients with postoperative delirium is still high ranging between 20-80%. Although postoperative delirium is a frequent complication and is associated with the need for more inpatient hospital care and longer length of hospital stay, little is known about risk factors for recovery room delirium (RRD) occurred in postanaesthesia care unit. The aim of the study was to determine pre- and intraoperative risk factors for the development of RRD among patients undergoing non cardiovascular surgery.

Study Overview

Status

Completed

Conditions

Detailed Description

Recovery room delirium (RRD) defined as delirium occurred in PACU was diagnosed according to CAM-ICU criteria. Pre-, intra-, and postoperative data of patients undergoing elective non cardiovascular surgery were prospectively collected, univariate and multivariate logistic regression were performed to find the risk factors related to postoperative delirium.

Study Type

Observational

Enrollment (Actual)

228

Contacts and Locations

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

Study Locations

    • Hubei
      • Wuhan, Hubei, China, 430030
        • Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients over the age of 18yr, who were admitted to the PACU after elective surgery under general anaesthesia during regular working hours (9:00Am to 5:00Pm)

Description

Inclusion Criteria:

  • elective non-cardiovascular surgery
  • general anesthesia

Exclusion Criteria:

  • under 18yr of age
  • under regional anaesthesia
  • refused to sign consent form
  • history of substance dependence
  • underwent neurosurgery
  • history of primary neurologic diseases
  • stayed less than 10min in PACU
  • received general anaesthesia but recovered in locations outside the recovery room

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

Cohorts and Interventions

Group / Cohort
Delirium
Delirium was determined by CAM-ICU
no Delirium
no Delirium was determined by CAM-ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of delirium in post anesthesia care unit (PACU) determined by confusion assessment method (CAM) -ICU criteria
Time Frame: at 1 hour after operation
at 1 hour after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate in PACU
Time Frame: every 10 mins
heart rate was recorded every 10 min during PACU stay, maximal and minimal heart rate were collected for analysis
every 10 mins
Pulse Oximeter Oxygen Saturation (SpO2) in PACU
Time Frame: every 10 mins
every 10 mins
Hospital-length of stay
Time Frame: up to 6 months
up to 6 months
Total health care fees
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

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

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

June 1, 2010

Primary Completion (Actual)

June 30, 2010

Study Completion (Actual)

June 30, 2010

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

October 7, 2009

First Posted (Estimate)

October 8, 2009

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

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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