Skip to content

Sevoflurane and Propofol Anesthesia on Postoperative Delirium

Comparison of Sevoflurane and Propofol Anesthesia on Postoperative Delirium in Geriatric Patients

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01995214
Enrollment
500
Registered
2013-11-26
Start date
2013-06-30
Completion date
Unknown
Last updated
2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia, Geriatric Patient

Keywords

Postoperative delirium, Geriatric, General anesthesia, Propofol, Sevoflurane

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.

Interventions

DRUGPropofol

Anesthesia maintenance with propofol+remifentanil guided by Narcotrend index monitoring.

DRUGSevoflurane

Anesthesia maintenance with sevoflurane+remifentanil guided by Narcrotrend index monitoring.

Sponsors

Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative deliriumat 24 postoperative hoursPostoperative delirium was determined by Confusion Assessment Method (CAM) at 24 postoperative hours

Secondary

MeasureTime frameDescription
Hemodynamic parameters5min, 10min, 20min, 30min after induction, 5min, 10min, 20min, 30min after skin incision, 5min, 10min, 20min, 30min before incision closureHart frequency, systolic blood pressure, diastolic blood pressure
Incidence of postoperative nausea and vomiting24 postoperative hoursIncidence of postoperative nausea and vomiting
Length of postanesthesia care unit (PACU) stayup to 2 hours after PACU admittingLength of PACU stay (min)
Postoperative delirium2st, 3st, 7st postoperative daysPostoperative delirium was determined by CAM every day at 2st, 3st, 7st postoperative days
Postoperative Stroke1st, 2st, 3st, 7st postoperative daysPostoperative Stroke will be determined by National Institutes of Health Stroke Scale (NIHSS)
Quality of recovery determined by quality of recovery (QOR-40; maximum score 200) score1,2,3,7 postoperative daysQuality of recovery determined by QOR-40

Countries

China

Contacts

Primary ContactWei Mei, MD., PhD
wmei@tjh.tjmu.edu.cn00862783663173

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026