Clinical trial NCT01995214: Sevoflurane and Propofol Anesthesia on Postoperative Delirium
Official title: Comparison of Sevoflurane and Propofol Anesthesia on Postoperative Delirium in Geriatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: General Anesthesia
Geriatric Patient
Keywords: Postoperative delirium
Geriatric
General anesthesia
Propofol
Sevoflurane
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Postoperative delirium
timeFrame: at 24 postoperative hours
Secondary outcomes:
measure: Length of postanesthesia care unit (PACU) stay
timeFrame: up to 2 hours after PACU admitting
measure: Hemodynamic parameters
timeFrame: 5min, 10min, 20min, 30min after induction, 5min, 10min, 20min, 30min after skin incision, 5min, 10min, 20min, 30min before incision closure
measure: Incidence of postoperative nausea and vomiting
timeFrame: 24 postoperative hours
measure: Quality of recovery determined by quality of recovery (QOR-40; maximum score 200) score
timeFrame: 1,2,3,7 postoperative days
measure: Postoperative delirium
timeFrame: 2st, 3st, 7st postoperative days
measure: Postoperative Stroke
timeFrame: 1st, 2st, 3st, 7st postoperative days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Yuke Tian, MD., PhD.
role: STUDY_CHAIR
References: