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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

August 5, 2014
August 11, 2014
September 25, 2017
September 2014
July 2018   (Final data collection date for primary outcome measure)
the incidence of POD in 7 days post operation [ Time Frame: in 7 days post operation ]
POD diagnosed with Confusion Assessment Method(CAM)
Same as current
Complete list of historical versions of study NCT02213380 on ClinicalTrials.gov Archive Site
  • 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)
  • Acute pain score using visual analogue scale (VAS) [ Time Frame: In 7days post operation ]
  • 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.
  • Length of hospital stay [ Time Frame: on the day of discharge from hospital ]
  • severity of delirium [ Time Frame: in 7days post operation ]
    severity of delirium was diagnosed with the DRS-R-98
  • duration of delirium [ Time Frame: in 7days post operation ]
    diagnosed with CAM
  • 30 day mortality [ Time Frame: 30 days after surgery ]
  • 6 months incidence of delirium [ Time Frame: 6 months after discharge ]
    in clinic or at their residence, diagnosed with CAM
  • 12 months incidence of delirium [ Time Frame: 12 months after discharge ]
    in clinic or at their residence, diagnosed with CAM
  • 6 months quality of life [ Time Frame: 6 months after discharge ]
    using SF-36 questionnaire
  • 12 months quality of life [ Time Frame: 12months after discharge ]
    using SF-36 questionnaire
Same as current
Not Provided
Not Provided
 
Effect of Anesthesia on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery
Effect of Regional Anaesthesia and General Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Surgery: a Multicenter Randomized Controlled Trial.
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.

Postoperative delirium (POD) is an acute confusional state associated with changes in consciousness, arousal level and cognitive status. Elderly patients with hip fractures have the high incidence of delirium. The high risk factor of delirium include: Age 65 years or older, cognitive impairment/dementia, current hip fracture, severe illness and so on. Many previous studies predict that the majority of general anesthetic and sedative agents can favour postoperative delirium. However, none of studies have investigated the effect of general anesthesia and the effect of regional anesthesia and general anesthesia on the postoperative delirium in elderly patients undergoing hip fracture surgery in China. This multicentre, prospective, randomized controlled clinical trial is designed to 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.

This trial has the following nine investigational centers: Department of Anesthesiology, The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University, Wenzhou, China; Department of Anesthesiology, Tongji Hospital, Tongji Medical college, Huazhong University of Science & Technology, Wuhan, China; Department of Anesthesiology, West China Hospital of Sichuan University, Chengdu, China; Department of Anesthesiology, Southwest Hospital, Chongqing, China; Department of Anesthesiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China; Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China; Department of Anesthesiology, The First Affiliated Hospital of Nanchang University, Nanchang, China; Department of Anesthesiology, The Second Hospital of Anhui Medical University, Anhui, China; The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China;

Eligible patients will be assigned into two study groups (group RA: regional anesthesia will be used, group GA: General anesthesia will be used) by centre-minimization randomization (web or telephone). There are 3 stratification factors: age (65-79,≥80), presence of delirium(yes, no), dementia(yes, no). There will be two teams of investigators involved in trial procedure and the patient's follow-up. Investigator A (experienced anesthetist), who are competent in caring for patients undergoing hip fracture surgery, will perform following works, which includes informed consent, randomization, anesthesia and recovery parameters. Investigator B will visit patient the day before surgery and 7days after surgery or until discharge to assess patient for presence, type and severity of delirium, collect other data during in hospital stay and follow up patients at 6 and 12 months. Investigator B will receive uniform training of using of CAM, Delirium Rating Scale-Revised-98 (DRS-R-98), MMSE and other test used in this trial) and will be not clear about protocol.

Within 24 h before surgery, cognitive function of each patient will be assessed with the MMSE, the presence of delirium will be diagnosed with the CAM, the type and severity of delirium will be assessed with DRS-R-98 and the pain will be assessed with a 100-mm visual analog scale (VAS). Routine monitoring (NBP, continuous ECG, and pulse oximetry) was initiated on all patients. Premedication for anesthesia will be avoided before surgery. Any medication impairing cognitive function will not be recommended, if administered, must be recorded it in detail.

Investigator A will allocated the patient into group GA or group RA according the centre-randomization with a unique registration number for each eligible patient. Treatment protocols for both groups will also stipulate no sedative be administrated during operation. Routine monitoring was initiated on all patients. Hypotension (Systolic Blood Pressure<90mmHg or drop of Mean Arterial Pressure>30%) should be treated with vasoactive agents or fluid boluses as deemed appropriate by anesthetists.

Postoperative analgesia will be administered according to the local procedures of each clinical trial site, aiming to maintain a VAS pain score ≤ 30 mm. Both groups will receive routine postoperative care on orthopedic ward.

All randomized patients will be followed up to 7 days after surgery (or discharge from the hospital). The 7 days follow-up includes: CAM, DRS-98-R (if applicable), VAS, Analgesic use (if applicable), Sedative use (if applicable), Post-operative morbidity and laboratory results (including serum hemoglobin, hematocrit, leucocytes, aspartate aminotransferase (AST), alanine aminotransferase (ALT), albumin, serum creatinine and urea concentrations, serum sodium and potassium and serum glucose concentration). Concomitant medications, adverse events and serious adverse events are record in all study visits. Economic parameters include: time to be discharged from post operation, total cost in hospital and cost for anesthesia of patient. Investigator B will also assess patient with POD in clinic or at their residence at 6 and 12 months to assess for presence of delirium, its type and severity (CAM, DRS-98-R), cognitive function using MMSE, and quality of life using The MOS 36-item Short-Form Health Survey (SF-36) questionnaire.

The study will be monitored regularly by the clinical research associate (CRA) through visits or telephone. CRA will verify the consistency of the data recorded on the case report forms with the source documents and the management of therapeutic batches, the presence and completeness of the investigator file.

Interventional
Not Applicable
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
Post Operative Delirium
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 GA
    Method of anesthesia: general anesthesia
    Intervention: Procedure: method of anesthesia
  • group RA
    Method of anesthesia: regional anesthesia
    Intervention: Procedure: method of anesthesia

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Same as current
July 2019
July 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Older Adult)
No
Contact: Ting LI, M.D. 00447570150148 liting1021@aliyun.com
Contact: Sishi Chen 008613957753282 chensishiwz@163.com
China
 
 
NCT02213380
RAGA-Delirium
Yes
Not Provided
Not Provided
Ting Li, Wenzhou Medical University
Wenzhou Medical University
National Research Institute for Family Planning, China
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
Wenzhou Medical University
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP