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Trial record 5 of 6 for:    20042557 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02213380
Recruitment Status : Recruiting
First Posted : August 11, 2014
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
National Research Institute for Family Planning, China
Information provided by (Responsible Party):
Ting Li, Wenzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Post Operative Delirium Procedure: method of anesthesia Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Effect of Regional Anaesthesia and General Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Surgery: a Multicenter Randomized Controlled Trial.
Study Start Date : September 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
group GA
Method of anesthesia: general anesthesia
Procedure: method of anesthesia

Method of anesthesia includes: 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 RA
Method of anesthesia: regional anesthesia
Procedure: method of anesthesia

Method of anesthesia includes: 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





Primary Outcome Measures :
  1. the incidence of POD in 7 days post operation [ Time Frame: in 7 days post operation ]
    POD diagnosed with Confusion Assessment Method(CAM)


Secondary Outcome Measures :
  1. The type of delirium diagnosed in 7 days post operation [ Time Frame: in 7 days post operation ]
    The type of delirium diagnosed with the Delirium Rating Scale-Revised-98 (DRS-R-98)

  2. Acute pain score using visual analogue scale (VAS) [ Time Frame: In 7days post operation ]
  3. Post-operative morbidity [ Time Frame: up to hospital discharge or death post operation ]
    including chest infection, myocardial infarction, renal failure, gastrointestinal ileus and so on.

  4. Length of hospital stay [ Time Frame: on the day of discharge from hospital ]
  5. severity of delirium [ Time Frame: in 7days post operation ]
    severity of delirium was diagnosed with the DRS-R-98

  6. duration of delirium [ Time Frame: in 7days post operation ]
    diagnosed with CAM

  7. 30 day mortality [ Time Frame: 30 days after surgery ]
  8. 6 months incidence of delirium [ Time Frame: 6 months after discharge ]
    in clinic or at their residence, diagnosed with CAM

  9. 12 months incidence of delirium [ Time Frame: 12 months after discharge ]
    in clinic or at their residence, diagnosed with CAM

  10. 6 months quality of life [ Time Frame: 6 months after discharge ]
    using SF-36 questionnaire

  11. 12 months quality of life [ Time Frame: 12months after discharge ]
    using SF-36 questionnaire



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213380


Contacts
Contact: Ting LI, M.D. 00447570150148 liting1021@aliyun.com
Contact: Sishi Chen 008613957753282 chensishiwz@163.com

Locations
China, Anhui
The Second Hospital of Anhui Medical University Not yet recruiting
Hefei, Anhui, China, 230601
Contact: Lijun Weng, M.D.    008613866774426    13866774426@126.com   
Principal Investigator: Ye Zhang, M.D.         
China, Hubei
Tongji Hospital, Tongji Medical college Recruiting
Wuhan, Hubei, China, 430030
Contact: Yuke Tian, M.D.    008613006162508    yktian@tjh.tjmu.edu.cn   
Contact: Wei Mei, M.D.    008613006162508    wmei@hust.edu.cn   
Principal Investigator: Yuke Tian, M.D.         
Sub-Investigator: Wei Mei, M.D.         
China, Jiangxi
The First Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330006
Contact: Xiaoping Zhu, M.D.    008613907915506    13907915506@163.com   
Principal Investigator: Fuquan Luo, M.D.         
China, Sichuan
West China Hospital of Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: Yanjun Lin, M.D.    008618980601624    18980601624@163.com   
Principal Investigator: Ren Liao, M.D.         
China, Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine Not yet recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Ping Gao, M.D.    13958127671    gaoping1999@hotmail.com   
Principal Investigator: Min Yan, M.D.         
The People's Hospital of Lishi Recruiting
Lishi, Zhejiang, China, 323000
Contact: LiHua Fang    008618957090898      
The Central Hospital of Lishui City Recruiting
Lishui, Zhejiang, China, 323000
Contact: LIPEI LEI    008613905883848      
Ningbo No.2 Hospital Recruiting
Ningbo, Zhejiang, China, 315010
Contact: GUORONG WU, M.D.    13600628721    13600628721@163.com   
Ningbo No.6 Hospital Recruiting
Ningbo, Zhejiang, China, 315040
Contact: GUORONG WU    008613600628721      
Taizhou Hospital of Zhejiang Province Recruiting
Taizhou, Zhejiang, China, 317000
Contact: MINGCANG WANG    008613757616856      
The First Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Xuzhong Xu, M.D.    008613706657799    xuzhong@263.net   
Principal Investigator: Xuzhong Xu, M.D.         
China
Beijing Jishuitan Hospital Not yet recruiting
Beijing, China, 100000
Contact: Bingxue Liu, M.D.    13661188006    snowdon@sohu.com   
Principal Investigator: Geng Wang, M.D.         
Southwest Hospital Not yet recruiting
Chongqing, China, 400038
Contact: Ting Zhao, M.D.    13983956536    273691504@qq.com   
Principal Investigator: Kaizhi Lu, M.D.         
Sponsors and Collaborators
Wenzhou Medical University
National Research Institute for Family Planning, China
Investigators
Study Chair: 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 Director: Jun Li, M.D. The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
Principal Investigator: Ting Li, M.D. The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
Study Director: Joice Yeung, M.D. HEART of ENGLAND NHS Foundation Trust
Study Director: Teresa Moledy HEART of ENGLAND NHS Foundation Trust

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ting Li, associate chief physician, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT02213380     History of Changes
Other Study ID Numbers: RAGA-Delirium
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by Ting Li, Wenzhou Medical University:
delirium
general anesthesia
regional anesthesia
elderly patient
hip fracture

Additional relevant MeSH terms:
Delirium
Hip Fractures
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs