Effect of Anesthesia on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery

NCT02213380 | Completed Results DMC

• 1 other identifier: RAGA-Delirium
• Study Type: interventional
• Target: 950
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is evaluate postoperative delirium after general anesthesia and regional anesthesia in elderly patients undergoing hip fracture surgery. Our research hypotheses are: (1) regional anesthesia may contribute to decrease the incidence of postoperative delirium. (2) Regional anesthesia may improve the outcome of elderly patient and reduce healthcare costs associated with postoperative delirium. (3) Postoperative delirium may result in poor long-term functional outcomes.

Conditions

Post Operative Delirium

Keywords

delirium; general anesthesia; regional anesthesia; elderly patient; hip fracture

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Post-operative Delirium in 7 Days Post Operation

  Post-operative delirium diagnosed with Confusion Assessment Method

  in 7 days post operation

Secondary Outcomes (12)

• Number of Participants With Post-operative Delirium

  within fist 7days post operation

• Severity of Delirium

  within first 7days post operation

• The Subtypes of Delirium Diagnosed in 7 Days Post Operation

  within first 7 days post operation

• 30 Day Mortality

  30 days after surgery

• Acute Pain Score Using Visual Analogue Scale (VAS)

  In 7days post operation

Study Arms (2)

group GA

OTHER

General anesthesia

Procedure: method of anesthesia

group RA

OTHER

Regional anesthesia

Procedure: method of anesthesia

Interventions

method of anesthesia PROCEDURE

General anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA

group GA; group RA

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• older patient (≥65 years)
• patient with hip fracture and planned hip fracture surgery
• patient willing to complete this study.

You may not qualify if:

• patient with multiple trauma or multiple fractures, pathological fractures, pelvic fractures, femur fractures
• contraindication (serious illness or medical conditions) for general anesthesia
• contraindication (infection at the site of needle insertion, coagulopathy, international normalized ratio \>1.4, platelet count \<80×109 litre-1, allergy to local anaesthetics and so on) for regional anesthesia;
• patient who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial
• patient known to susceptible to malignant hyperthermia
• known allergy or hypersensitivity to any drugs administered during this clinical trial
• previous participation in this clinical trial
• participation in another clinical trial within 4 weeks prior to selection

Sponsors & Collaborators

• Wenzhou Medical University: lead
• National Research Institute for Family Planning, China: collaborator

Study Sites (13)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Tongji Hospital, Tongji Medical college

Wuhan, Hubei, 430030, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

The People's Hospital of Lishi

Lishi, Zhejiang, 323000, China

Location

The Central Hospital of Lishui City

Lishui, Zhejiang, 323000, China

Location

Ningbo No.2 Hospital

Ningbo, Zhejiang, 315010, China

Location

Ningbo No.6 Hospital

Ningbo, Zhejiang, 315040, China

Location

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317000, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Beijing Jishuitan Hospital

Beijing, 100000, China

Location

Southwest Hospital

Chongqing, 400038, China

Location

Related Publications (25)

• Sanders RD, Pandharipande PP, Davidson AJ, Ma D, Maze M. Anticipating and managing postoperative delirium and cognitive decline in adults. BMJ. 2011 Jul 20;343:d4331. doi: 10.1136/bmj.d4331. No abstract available.

  PMID: 21775401 BACKGROUND

• Marcantonio ER, Flacker JM, Wright RJ, Resnick NM. Reducing delirium after hip fracture: a randomized trial. J Am Geriatr Soc. 2001 May;49(5):516-22. doi: 10.1046/j.1532-5415.2001.49108.x.

  PMID: 11380742 BACKGROUND

• Bruce AJ, Ritchie CW, Blizard R, Lai R, Raven P. The incidence of delirium associated with orthopedic surgery: a meta-analytic review. Int Psychogeriatr. 2007 Apr;19(2):197-214. doi: 10.1017/S104161020600425X. Epub 2006 Sep 14.

  PMID: 16973101 BACKGROUND

• Furlaneto ME, Garcez-Leme LE. Delirium in elderly individuals with hip fracture: causes, incidence, prevalence, and risk factors. Clinics (Sao Paulo). 2006 Feb;61(1):35-40. doi: 10.1590/s1807-59322006000100007. Epub 2006 Mar 10.

  PMID: 16532223 BACKGROUND

• Nie H, Zhao B, Zhang YQ, Jiang YH, Yang YX. Pain and cognitive dysfunction are the risk factors of delirium in elderly hip fracture Chinese patients. Arch Gerontol Geriatr. 2012 Mar-Apr;54(2):e172-4. doi: 10.1016/j.archger.2011.09.012. Epub 2011 Oct 19.

  PMID: 22014763 BACKGROUND

• Eeles EM, Hubbard RE, White SV, O'Mahony MS, Savva GM, Bayer AJ. Hospital use, institutionalisation and mortality associated with delirium. Age Ageing. 2010 Jul;39(4):470-5. doi: 10.1093/ageing/afq052.

  PMID: 20554540 BACKGROUND

• Zakriya K, Sieber FE, Christmas C, Wenz JF Sr, Franckowiak S. Brief postoperative delirium in hip fracture patients affects functional outcome at three months. Anesth Analg. 2004 Jun;98(6):1798-1802. doi: 10.1213/01.ANE.0000117145.50236.90.

  PMID: 15155351 BACKGROUND

• Kat MG, Vreeswijk R, de Jonghe JF, van der Ploeg T, van Gool WA, Eikelenboom P, Kalisvaart KJ. Long-term cognitive outcome of delirium in elderly hip surgery patients. A prospective matched controlled study over two and a half years. Dement Geriatr Cogn Disord. 2008;26(1):1-8. doi: 10.1159/000140611. Epub 2008 Jul 9.

  PMID: 18562793 BACKGROUND

• Kat MG, de Jonghe JF, Vreeswijk R, van der Ploeg T, van Gool WA, Eikelenboom P, Kalisvaart KJ. Mortality associated with delirium after hip-surgery: a 2-year follow-up study. Age Ageing. 2011 May;40(3):312-8. doi: 10.1093/ageing/afr014. Epub 2011 Mar 17.

  PMID: 21414946 BACKGROUND

• Fong TG, Jones RN, Shi P, Marcantonio ER, Yap L, Rudolph JL, Yang FM, Kiely DK, Inouye SK. Delirium accelerates cognitive decline in Alzheimer disease. Neurology. 2009 May 5;72(18):1570-5. doi: 10.1212/WNL.0b013e3181a4129a.

  PMID: 19414723 BACKGROUND

• Witlox J, Slor CJ, Jansen RW, Kalisvaart KJ, van Stijn MF, Houdijk AP, Eikelenboom P, van Gool WA, de Jonghe JF. The neuropsychological sequelae of delirium in elderly patients with hip fracture three months after hospital discharge. Int Psychogeriatr. 2013 Sep;25(9):1521-31. doi: 10.1017/S1041610213000574. Epub 2013 May 7.

  PMID: 23651760 BACKGROUND

• Cole MG. Persistent delirium in older hospital patients. Curr Opin Psychiatry. 2010 May;23(3):250-4. doi: 10.1097/YCO.0b013e32833861f6.

  PMID: 20224406 BACKGROUND

• Young J, Murthy L, Westby M, Akunne A, O'Mahony R; Guideline Development Group. Diagnosis, prevention, and management of delirium: summary of NICE guidance. BMJ. 2010 Jul 28;341:c3704. doi: 10.1136/bmj.c3704. No abstract available.

  PMID: 20667955 BACKGROUND

• Sanders RD. Hypothesis for the pathophysiology of delirium: role of baseline brain network connectivity and changes in inhibitory tone. Med Hypotheses. 2011 Jul;77(1):140-3. doi: 10.1016/j.mehy.2011.03.048. Epub 2011 Apr 16.

  PMID: 21498007 BACKGROUND

• Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.

  PMID: 9525362 BACKGROUND

• Rasmussen LS, Johnson T, Kuipers HM, Kristensen D, Siersma VD, Vila P, Jolles J, Papaioannou A, Abildstrom H, Silverstein JH, Bonal JA, Raeder J, Nielsen IK, Korttila K, Munoz L, Dodds C, Hanning CD, Moller JT; ISPOCD2(International Study of Postoperative Cognitive Dysfunction) Investigators. Does anaesthesia cause postoperative cognitive dysfunction? A randomised study of regional versus general anaesthesia in 438 elderly patients. Acta Anaesthesiol Scand. 2003 Mar;47(3):260-6. doi: 10.1034/j.1399-6576.2003.00057.x.

  PMID: 12648190 BACKGROUND

• Sieber FE, Zakriya KJ, Gottschalk A, Blute MR, Lee HB, Rosenberg PB, Mears SC. Sedation depth during spinal anesthesia and the development of postoperative delirium in elderly patients undergoing hip fracture repair. Mayo Clin Proc. 2010 Jan;85(1):18-26. doi: 10.4065/mcp.2009.0469.

  PMID: 20042557 BACKGROUND

• Abou-Setta AM, Beaupre LA, Rashiq S, Dryden DM, Hamm MP, Sadowski CA, Menon MR, Majumdar SR, Wilson DM, Karkhaneh M, Mousavi SS, Wong K, Tjosvold L, Jones CA. Comparative effectiveness of pain management interventions for hip fracture: a systematic review. Ann Intern Med. 2011 Aug 16;155(4):234-45. doi: 10.7326/0003-4819-155-4-201108160-00346.

  PMID: 21844549 BACKGROUND

• Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

  PMID: 2240918 BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Trzepacz PT, Mittal D, Torres R, Kanary K, Norton J, Jimerson N. Validation of the Delirium Rating Scale-revised-98: comparison with the delirium rating scale and the cognitive test for delirium. J Neuropsychiatry Clin Neurosci. 2001 Spring;13(2):229-42. doi: 10.1176/jnp.13.2.229.

  PMID: 11449030 BACKGROUND

• Huang MC, Lee CH, Lai YC, Kao YF, Lin HY, Chen CH. Chinese version of the Delirium Rating Scale-Revised-98: reliability and validity. Compr Psychiatry. 2009 Jan-Feb;50(1):81-5. doi: 10.1016/j.comppsych.2008.05.011. Epub 2008 Aug 23.

  PMID: 19059519 BACKGROUND

• McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994 Jan;32(1):40-66. doi: 10.1097/00005650-199401000-00004.

  PMID: 8277801 BACKGROUND

• Li T, Li J, Yuan L, Wu J, Jiang C, Daniels J, Mehta RL, Wang M, Yeung J, Jackson T, Melody T, Jin S, Yao Y, Wu J, Chen J, Smith FG, Lian Q; RAGA Study Investigators. Effect of Regional vs General Anesthesia on Incidence of Postoperative Delirium in Older Patients Undergoing Hip Fracture Surgery: The RAGA Randomized Trial. JAMA. 2022 Jan 4;327(1):50-58. doi: 10.1001/jama.2021.22647.

  PMID: 34928310 DERIVED

• Li T, Yeung J, Li J, Zhang Y, Melody T, Gao Y, Wang Y, Lian Q, Gao F; RAGA-Delirium Investigators. Comparison of regional with general anaesthesia on postoperative delirium (RAGA-delirium) in the older patients undergoing hip fracture surgery: study protocol for a multicentre randomised controlled trial. BMJ Open. 2017 Oct 22;7(10):e016937. doi: 10.1136/bmjopen-2017-016937.

  PMID: 29061612 DERIVED

MeSH Terms

Conditions

Emergence Delirium; Delirium; Hip Fractures

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Results Point of Contact

• Title: Ting Li
• Organization: The second affiliated hospital and Yuying children's hospital of Wenzhou medical university

liting1021@aliyun.com

008613587876896

Study Officials

• Fang Gao, M.D.

  The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University

  STUDY CHAIR

• Qingquan Lian, M.D.

  The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University

  STUDY CHAIR

• Jun Li, M.D.

  The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University

  STUDY DIRECTOR

• Ting Li, M.D.

  The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Joice Yeung, M.D.

  Heart of England NHS Foundation Trust

  STUDY DIRECTOR

• Teresa Moledy

  Heart of England NHS Foundation Trust

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors or outcome assessors, e.g. the medical staff who provide post-operative care in the ward and visit patients for preoperational assessment, hospital visits and subsequent follow-ups, will be blinded from group allocation throughout the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 11, 2014
• Study Start: September 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: January 1, 2020
• Last Updated: May 9, 2024
• Results First Posted: January 28, 2021

Record last verified: 2024-04

Locations

CN (13)