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Sevoflurane and Propofol Anesthesia on Postoperative Delirium

NCT ID: NCT01995214

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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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

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Conditions

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General Anesthesia Geriatric Patient

Keywords

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Postoperative delirium Geriatric General anesthesia Propofol Sevoflurane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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P

Anesthesia maintenance with propofol+remifentanil

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

S

Anesthesia maintenance with sevoflurane+remifentanil

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

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

Interventions

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Propofol

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

Intervention Type DRUG

Sevoflurane

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Wei Mei

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuke Tian, MD., PhD.

Role: STUDY_CHAIR

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Mei, MD., PhD

Role: CONTACT

Phone: 00862783663173

Email: [email protected]

Facility Contacts

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Wei Mei, MD., PhD.

Role: primary

Other Identifiers

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TJMZK20130602

Identifier Type: -

Identifier Source: org_study_id