Sevoflurane and Propofol Anesthesia on Postoperative Delirium

Phase 4

• Conditions: General Anesthesia; Geriatric Patient
• Interventions: Drug: Propofol; Drug: Sevoflurane

• Registration Number: NCT01995214
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Status Verified: 2013-11
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-21
• Last Update Submitted: 2013-11-21
• Study First Posted: 2013-11-26
• Last Update Posted: 2013-11-26
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	Propofol	Anesthesia maintenance with propofol+remifentanil
S	Sevoflurane	Anesthesia maintenance with sevoflurane+remifentanil

Primary Outcome Measures

Name	Time	Method
Postoperative delirium	at 24 postoperative hours	Postoperative delirium was determined by Confusion Assessment Method (CAM) at 24 postoperative hours

Secondary Outcome Measures

Name	Time	Method
Length of postanesthesia care unit (PACU) stay	up to 2 hours after PACU admitting	Length of PACU stay (min)
Hemodynamic parameters	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	24 postoperative hours	Incidence of postoperative nausea and vomiting
Quality of recovery determined by quality of recovery (QOR-40; maximum score 200) score	1,2,3,7 postoperative days	Quality of recovery determined by QOR-40
Postoperative delirium	2st, 3st, 7st postoperative days	Postoperative delirium was determined by CAM every day at 2st, 3st, 7st postoperative days
Postoperative Stroke	1st, 2st, 3st, 7st postoperative days	Postoperative Stroke will be determined by National Institutes of Health Stroke Scale (NIHSS)

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China