The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium
NCT ID: NCT02305589
Last Updated: 2015-12-16
Study Results
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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UNKNOWN
250 participants
OBSERVATIONAL
2014-09-30
2016-11-30
Brief Summary
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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).
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Sugammadex
Muscle relax reversing agent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. preoperative neurologic or psychological problem including dementia, Parkinson's disease or delirium
3. other concurrent surgery.
60 Years
ALL
No
Sponsors
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Konkuk University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Seong-Hyop Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Konkuk University Medical Center
Locations
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Konkuk University Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Seoung-Hyop Kim, M.D,Ph.D
Role: primary
References
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Krenk L, Rasmussen LS. Postoperative delirium and postoperative cognitive dysfunction in the elderly - what are the differences? Minerva Anestesiol. 2011 Jul;77(7):742-9.
Zywiel MG, Prabhu A, Perruccio AV, Gandhi R. The influence of anesthesia and pain management on cognitive dysfunction after joint arthroplasty: a systematic review. Clin Orthop Relat Res. 2014 May;472(5):1453-66. doi: 10.1007/s11999-013-3363-2.
Plaud B, Debaene B, Donati F, Marty J. Residual paralysis after emergence from anesthesia. Anesthesiology. 2010 Apr;112(4):1013-22. doi: 10.1097/ALN.0b013e3181cded07. No abstract available.
Other Identifiers
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KUH1160075
Identifier Type: -
Identifier Source: org_study_id