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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02305589
Other study ID # KUH1160075
Secondary ID
Status Recruiting
Phase N/A
First received November 17, 2014
Last updated December 14, 2015
Start date September 2014
Est. completion date November 2016

Study information

Verified date December 2015
Source Konkuk University Medical Center
Contact Seong-Hyop Kim, M.D., Ph.D.
Phone 82-2-2030-5454
Email yshkim75@daum.net
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date November 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Drug:
Sugammadex
Muscle relax reversing agent

Locations

Country Name City State
Korea, Republic of Konkuk University Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of postoperative delirium up to postoperative 7 days No
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