Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Sevoflurane and Propofol Anesthesia on Postoperative Delirium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
General Anesthesia Geriatric Patient Drug: Propofol Drug: Sevoflurane Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Sevoflurane and Propofol Anesthesia on Postoperative Delirium in Geriatric Patients
Study Start Date : June 2013
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: P
Anesthesia maintenance with propofol+remifentanil
Drug: Propofol
Anesthesia maintenance with propofol+remifentanil guided by Narcotrend index monitoring.

Experimental: S
Anesthesia maintenance with sevoflurane+remifentanil
Drug: Sevoflurane
Anesthesia maintenance with sevoflurane+remifentanil guided by Narcrotrend index monitoring.




Primary Outcome Measures :
  1. Postoperative delirium [ Time Frame: at 24 postoperative hours ]
    Postoperative delirium was determined by Confusion Assessment Method (CAM) at 24 postoperative hours


Secondary Outcome Measures :
  1. Length of postanesthesia care unit (PACU) stay [ Time Frame: up to 2 hours after PACU admitting ]
    Length of PACU stay (min)

  2. 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

  3. Incidence of postoperative nausea and vomiting [ Time Frame: 24 postoperative hours ]
    Incidence of postoperative nausea and vomiting

  4. 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

  5. Postoperative delirium [ Time Frame: 2st, 3st, 7st postoperative days ]
    Postoperative delirium was determined by CAM every day at 2st, 3st, 7st postoperative days

  6. Postoperative Stroke [ Time Frame: 1st, 2st, 3st, 7st postoperative days ]
    Postoperative Stroke will be determined by National Institutes of Health Stroke Scale (NIHSS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01995214


Contacts
Layout table for location contacts
Contact: Wei Mei, MD., PhD 00862783663173 wmei@tjh.tjmu.edu.cn

Locations
Layout table for location information
China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430030
Contact: Wei Mei, MD., PhD.    00862783663173    wmei@tjh.tjmu.edu.cn   
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Layout table for investigator information
Study Chair: Yuke Tian, MD., PhD. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Layout table for additonal information
Responsible Party: Wei Mei, Associate Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01995214    
Other Study ID Numbers: TJMZK20130602
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013
Keywords provided by Wei Mei, Huazhong University of Science and Technology:
Postoperative delirium
Geriatric
General anesthesia
Propofol
Sevoflurane
Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Remifentanil
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation