Sevoflurane and Propofol Anesthesia on Postoperative Delirium

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01995214
• Other study ID #: TJMZK20130602
• Status: Recruiting
• Phase: Phase 4
• First received: November 13, 2013
• Last updated: November 21, 2013
• Start date: June 2013

Study information

• Verified date: November 2013
• Source: Huazhong University of Science and Technology
• Contact: Wei Mei, MD., PhD
• Phone: 00862783663173
• Email: wmei[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• General Anesthesia
• Geriatric Patient

Intervention

Drug:
• Propofol
Anesthesia maintenance with propofol+remifentanil guided by Narcotrend index monitoring.
• Sevoflurane
Anesthesia maintenance with sevoflurane+remifentanil guided by Narcrotrend index monitoring.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative delirium	Postoperative delirium was determined by Confusion Assessment Method (CAM) at 24 postoperative hours	at 24 postoperative hours	Yes
Secondary	Length of postanesthesia care unit (PACU) stay	Length of PACU stay (min)	up to 2 hours after PACU admitting	Yes
Secondary	Hemodynamic parameters	Hart frequency, systolic blood pressure, diastolic blood pressure	5min, 10min, 20min, 30min after induction, 5min, 10min, 20min, 30min after skin incision, 5min, 10min, 20min, 30min before incision closure	Yes
Secondary	Incidence of postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting	24 postoperative hours	Yes
Secondary	Quality of recovery determined by quality of recovery (QOR-40; maximum score 200) score	Quality of recovery determined by QOR-40	1,2,3,7 postoperative days	Yes
Secondary	Postoperative delirium	Postoperative delirium was determined by CAM every day at 2st, 3st, 7st postoperative days	2st, 3st, 7st postoperative days	Yes
Secondary	Postoperative Stroke	Postoperative Stroke will be determined by National Institutes of Health Stroke Scale (NIHSS)	1st, 2st, 3st, 7st postoperative days	Yes