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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 : Completed
First Posted : August 11, 2014
Results First Posted : January 28, 2021
Last Update Posted : January 28, 2021
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 950 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.
Actual Study Start Date : September 2014
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
group GA
General anesthesia
Procedure: method of anesthesia

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
Regional anesthesia
Procedure: method of anesthesia

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. Number of Participants With Post-operative Delirium in 7 Days Post Operation [ Time Frame: in 7 days post operation ]
    Post-operative delirium diagnosed with Confusion Assessment Method


Secondary Outcome Measures :
  1. Number of Participants With Post-operative Delirium [ Time Frame: within fist 7days post operation ]

    Number of participants with delirium includes patients who had delirium in the post in the first 7 post-operative days.

    The severity of delirium was described using a severity score from 0 (no delirium) to 39 (highest severity) and subtypes of delirium as hyperactive, hypoactive or mixed.


  2. Severity of Delirium [ Time Frame: within first 7days post operation ]
    The worst severity scores of delirium was diagnosed with the DRS-R-98 within 7 days

  3. The Subtypes of Delirium Diagnosed in 7 Days Post Operation [ Time Frame: within first 7 days post operation ]

    The subtypes of delirium diagnosed with the Delirium Rating Scale-Revised-98 (DRS-R-98).

    Patients with the hyperactive subtype may be agitated, disoriented, and delusional, and may experience hallucinations. This presentation can be confused with that of schizophrenia, agitated dementia, or a psychotic disorder.


  4. 30 Day Mortality [ Time Frame: 30 days after surgery ]
    Mortality within 30 days post operation

  5. Acute Pain Score Using Visual Analogue Scale (VAS) [ Time Frame: In 7days post operation ]
    The worst pain score within 7 days post-operation in both groups. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain(0 point) to worst pain (100 points).

  6. Length of Hospital Stay [ Time Frame: till the day of discharge from hospital, an average of 7 days ]
    Length of hospital stay are measured from the anesthesia starting day to the discharge day

  7. Costs of Anesthetic Procedure [ Time Frame: 1 day after operation ]
    Costs of anesthetic procedure only

  8. Total In-hospital Costs [ Time Frame: till the day of discharge ]
    Entire expenditure in-hospital

  9. 6 Months Incidence of Delirium [ Time Frame: 6 months after discharge ]
    in clinic or at their residence, diagnosed with Confusion Assessment Method (CAM)

  10. 12 Months Incidence of Delirium [ Time Frame: 12 months after discharge ]
    in clinic or at their residence, diagnosed with Confusion Assessment Method (CAM)

  11. 6 Months Quality of Life [ Time Frame: 6 months after discharge ]
    using 36-Item Short Form Survey (SF-36) questionnaire

  12. 12 Months Quality of Life [ Time Frame: 12months after discharge ]
    using 36-Item Short Form Survey (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


Locations
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China, Anhui
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
China, Hubei
Tongji Hospital, Tongji Medical college
Wuhan, Hubei, China, 430030
China, Jiangxi
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
China, Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
The People's Hospital of Lishi
Lishi, Zhejiang, China, 323000
The Central Hospital of Lishui City
Lishui, Zhejiang, China, 323000
Ningbo No.2 Hospital
Ningbo, Zhejiang, China, 315010
Ningbo No.6 Hospital
Ningbo, Zhejiang, China, 315040
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China, 317000
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
China
Beijing Jishuitan Hospital
Beijing, China, 100000
Southwest Hospital
Chongqing, China, 400038
Sponsors and Collaborators
Wenzhou Medical University
National Research Institute for Family Planning, China
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Ting Li, Wenzhou Medical University:
Statistical Analysis Plan  [PDF] February 15, 2019
Study Protocol  [PDF] July 8, 2014

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ting Li, associate chief physician, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT02213380    
Other Study ID Numbers: RAGA-Delirium
First Posted: August 11, 2014    Key Record Dates
Results First Posted: January 28, 2021
Last Update Posted: January 28, 2021
Last Verified: January 2021
Keywords provided by Ting Li, Wenzhou Medical University:
delirium
general anesthesia
regional anesthesia
elderly patient
hip fracture
Additional relevant MeSH terms:
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Delirium
Hip Fractures
Fractures, Bone
Wounds and Injuries
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Femoral Fractures
Hip Injuries
Leg Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs