A Phase 4 interventional study of Propofol and Sevoflurane in General Anesthesia and Geriatric Patient, sponsored by Huazhong University of Science and Technology. Status unknown at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2013-11-26.
Sponsored by Huazhong University of Science and Technology · Phase 4, Interventional, and Prevention
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 500 is above the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Anesthesia maintenance with propofol+remifentanil
Drug: Propofol
Anesthesia maintenance with sevoflurane+remifentanil
Drug: Sevoflurane
Anesthesia maintenance with propofol+remifentanil guided by Narcotrend index monitoring.
Anesthesia maintenance with sevoflurane+remifentanil guided by Narcrotrend index monitoring.
Postoperative delirium
Postoperative delirium was determined by Confusion Assessment Method (CAM) at 24 postoperative hours
Time frame: at 24 postoperative hours
Length of postanesthesia care unit (PACU) stay
Length of PACU stay (min)
Time frame: up to 2 hours after PACU admitting
Hemodynamic parameters
Hart frequency, systolic blood pressure, diastolic blood pressure
Time frame: 5min, 10min, 20min, 30min after induction, 5min, 10min, 20min, 30min after skin incision, 5min, 10min, 20min, 30min before incision closure
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting
Time frame: 24 postoperative hours
Quality of recovery determined by quality of recovery (QOR-40; maximum score 200) score
Quality of recovery determined by QOR-40
Time frame: 1,2,3,7 postoperative days
Postoperative delirium
Postoperative delirium was determined by CAM every day at 2st, 3st, 7st postoperative days
Time frame: 2st, 3st, 7st postoperative days
Postoperative Stroke
Postoperative Stroke will be determined by National Institutes of Health Stroke Scale (NIHSS)
Time frame: 1st, 2st, 3st, 7st postoperative days
This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Huazhong University of Science and Technology