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

NCT02305589 | Unknown

• 1 other identifier: KUH1160075
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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).

Conditions

Delirium

Keywords

postoperative delirium; sugammadex; cholinesterase inhibitor; hip fracture surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  up to postoperative 7 days

Interventions

Sugammadex DRUG

Muscle relax reversing agent

Also known as: Bridion

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing hip surgery under general anaesthesia with neuromuscular blocking agents

You may qualify if:

• Patients undergoing hip surgery under general anaesthesia with neuromuscular blocking agents

You may not qualify if:

• age \< 60 years
• preoperative neurologic or psychological problem including dementia, Parkinson's disease or delirium
• other concurrent surgery.

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, 143-729, South Korea

RECRUITING

Related 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.

  PMID: 21709661 RESULT

• 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.

  PMID: 24186470 RESULT

• 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.

  PMID: 20234315 RESULT

MeSH Terms

Conditions

Delirium; Emergence Delirium

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Seong-Hyop Kim, M.D., Ph.D.

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seong-Hyop Kim, M.D., Ph.D.

CONTACT

82-2-2030-5454; yshkim75@daum.net

Chung-Sik Oh, M.D.

CONTACT

82-2-2030-5457; ohcsik@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: December 2, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

KR (1)