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Sevoflurane and Propofol Anesthesia on Postoperative Delirium

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ClinicalTrials.gov Identifier: NCT01995214
Recruitment Status : Unknown
Verified November 2013 by Wei Mei, Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : November 26, 2013
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology

Tracking Information
First Submitted Date  ICMJE November 13, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date November 26, 2013
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
Postoperative delirium [ Time Frame: at 24 postoperative hours ]
Postoperative delirium was determined by Confusion Assessment Method (CAM) at 24 postoperative hours
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
  • Length of postanesthesia care unit (PACU) stay [ Time Frame: up to 2 hours after PACU admitting ]
    Length of PACU stay (min)
  • Hemodynamic parameters [ Time Frame: 5min, 10min, 20min, 30min after induction, 5min, 10min, 20min, 30min after skin incision, 5min, 10min, 20min, 30min before incision closure ]
    Hart frequency, systolic blood pressure, diastolic blood pressure
  • Incidence of postoperative nausea and vomiting [ Time Frame: 24 postoperative hours ]
    Incidence of postoperative nausea and vomiting
  • Quality of recovery determined by quality of recovery (QOR-40; maximum score 200) score [ Time Frame: 1,2,3,7 postoperative days ]
    Quality of recovery determined by QOR-40
  • Postoperative delirium [ Time Frame: 2st, 3st, 7st postoperative days ]
    Postoperative delirium was determined by CAM every day at 2st, 3st, 7st postoperative days
  • Postoperative Stroke [ Time Frame: 1st, 2st, 3st, 7st postoperative days ]
    Postoperative Stroke will be determined by National Institutes of Health Stroke Scale (NIHSS)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sevoflurane and Propofol Anesthesia on Postoperative Delirium
Official Title  ICMJE Comparison of Sevoflurane and Propofol Anesthesia on Postoperative Delirium in Geriatric Patients
Brief Summary Delirium is defined as an acute onset and fluctuating course of mental status change with inattention and an altered level of consciousness. Delirium in the postoperative period can be divided into emergence delirium and postoperative delirium, based on the time of onset (Silverstein et al., 2007).Postanaesthesia delirium is a frequent and potentially serious problem affecting the safety of patients and medical personnel. Clinical studies demonstrated that postoperative delirium is associated with worse outcomes such as prolonged hospital stay, postdischarge institutionalization, and increased mortality (Ely et al., 2004a; Thomason et al., 2005; Robinson et al., 2009). Multiple factors may contribute to the development of postoperative delirium, including patient's medical condition, administration of anesthetics or analgesics and degree of operative stress (Yildizeli et al., 2005; Robinson & Eiseman, 2008; Deiner & Silverstein, 2009). Sevoflurane anesthesia have been reported to be associated with more emergence delirium in pediatric patients, when compared with propofol anesthesia. It is not clear if propofol anesthesia will benefit the geriatric patients on postoperative delirium, when compared with sevoflurane anesthesia. We hypothesize that propofol anesthesia will reduce the rate of postoperative delirium by 50% when compared with sevoflurane anesthesia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • General Anesthesia
  • Geriatric Patient
Intervention  ICMJE
  • Drug: Propofol
    Anesthesia maintenance with propofol+remifentanil guided by Narcotrend index monitoring.
  • Drug: Sevoflurane
    Anesthesia maintenance with sevoflurane+remifentanil guided by Narcrotrend index monitoring.
Study Arms  ICMJE
  • Experimental: P
    Anesthesia maintenance with propofol+remifentanil
    Intervention: Drug: Propofol
  • Experimental: S
    Anesthesia maintenance with sevoflurane+remifentanil
    Intervention: Drug: Sevoflurane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 21, 2013)
500
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American Society of Anesthesiologists Physical Status classification (ASA_PS) class I-III
  • Aged 60 years or above
  • Elective major surgery under general anesthesia

Exclusion Criteria:

  • ASA_PS>=IV
  • Aged under 60 yr old
  • Body mass index (BMI) >30
  • Neurologic disease
  • Cardiac surgery and neurologic surgery
  • Anticonvulsant drugs
  • Chronic analgesics intake
  • Participating in the investigation of another study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01995214
Other Study ID Numbers  ICMJE TJMZK20130602
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wei Mei, Huazhong University of Science and Technology
Study Sponsor  ICMJE Huazhong University of Science and Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Yuke Tian, MD., PhD. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
PRS Account Huazhong University of Science and Technology
Verification Date November 2013

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