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

Sponsor
Konkuk University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02305589
Collaborator
(none)
250
1
26
9.6

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Comparison of Sugammadex and Conventional Cholinesterase Inhibitor on the Aspect of Postoperative Delirium in the Elderly Patients Undergoing Hip Surgery
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
May 1, 2016
Anticipated Study Completion Date :
Nov 1, 2016

Outcome Measures

Primary Outcome Measures

  1. Incidence of postoperative delirium [up to postoperative 7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Konkuk University Medical Center Seoul Korea, Republic of 143-729

Sponsors and Collaborators

  • Konkuk University Medical Center

Investigators

  • Principal Investigator: Seong-Hyop Kim, M.D., Ph.D., Konkuk University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Konkuk University Medical Center
ClinicalTrials.gov Identifier:
NCT02305589
Other Study ID Numbers:
  • KUH1160075
First Posted:
Dec 2, 2014
Last Update Posted:
Dec 16, 2015
Last Verified:
Dec 1, 2015
Keywords provided by Konkuk University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2015