DeliriumNCT02305589
The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium
An observational study of Delirium, run by Konkuk University Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Sugammadex
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing hip surgery under general anaesthesia with neuromuscular blocking agents
Who may be able to join
- Patients undergoing hip surgery under general anaesthesia with neuromuscular blocking agents
Who cannot join
- age < 60 years
- preoperative neurologic or psychological problem including dementia, Parkinson's disease or delirium
- other concurrent surgery.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University Medical Center
Seoul, 143-729
Seoung-Hyop Kim, M.D,Ph.D, 82-2-2030-5454, yshkim@daum.net
Seong-Hyop Kim, M.D,Ph.D
About this study
Official title: 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).
Read the 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
- age < 60 years
- preoperative neurologic or psychological problem including dementia, Parkinson's disease or delirium
- 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
- Delirium
- Being tested
- Sugammadex
- Keywords
- postoperative delirium, sugammadex, cholinesterase inhibitor, hip fracture surgery
- Medical subject headings
- Delirium, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion
Muscle relax reversing agent
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Measured: up to postoperative 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seong-Hyop Kim, M.D., Ph.D., Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305589
- Sponsor's protocol ID
- KUH1160075
- Status last verified
- Dec 2015
- First submitted
- 17 Nov 2014
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21709661Zywiel 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.
PubMed 24186470Plaud 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.
PubMed 20234315
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Sugammadex and Conventional Cholinesterase Inhibitor on the Aspect of Postoperative Delirium in the Elderly Patients Undergoing Hip Surgery
- ClinicalTrials.gov ID
- NCT02305589
- Acronym / sponsor ID
- KUH1160075
- Conditions
- Delirium
- Keywords
- postoperative delirium, sugammadex, cholinesterase inhibitor, hip fracture surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- age < 60 years
- preoperative neurologic or psychological problem including dementia, Parkinson's disease or delirium
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing hip surgery under general anaesthesia with neuromuscular blocking agents
Key inclusion criteria (1 listed)
- Patients undergoing hip surgery under general anaesthesia with neuromuscular blocking agents
Key exclusion criteria (3 listed)
- age < 60 years
- preoperative neurologic or psychological problem including dementia, Parkinson's disease or delirium
- other concurrent surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugammadexAlso: BridionMuscle relax reversing agent | Drug | – |
Primary outcome
Incidence of postoperative delirium
Time frame: up to postoperative 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
- Results publication: PubMed 21709661Krenk L, Rasmussen LS. Postoperative delirium and postoperative cognitive dysfunction in the elderly - what are the differences? Minerva Anestesiol. 2011 Jul;77(7):742-9.
- Results publication: PubMed 24186470Zywiel 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.
- Results publication: PubMed 20234315Plaud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seong-Hyop Kim, M.D., Ph.D. principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seong-Hyop Kim, M.D., Ph.D. (82-2-2030-5454, yshkim75@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: up to postoperative 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02305589, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.