Sevoflurane and Propofol Anesthesia on Postoperative Delirium

Study Overview
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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.

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

Conditions
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General Anesthesia, Geriatric Patient

Intervention / Treatment
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* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P<br>Anesthesia maintenance with propofol+remifentanil | Drug: Propofol<br>* Anesthesia maintenance with propofol+remifentanil guided by Narcotrend index monitoring.<br>|
| Experimental: S<br>Anesthesia maintenance with sevoflurane+remifentanil | Drug: Sevoflurane<br>* Anesthesia maintenance with sevoflurane+remifentanil guided by Narcrotrend index monitoring.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative delirium | Postoperative delirium was determined by Confusion Assessment Method (CAM) at 24 postoperative hours | at 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of postanesthesia care unit (PACU) stay | Length of PACU stay (min) | up to 2 hours after PACU admitting | 
| 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 | 
| Incidence of postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting | 24 postoperative hours | 
| 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 | 
| Postoperative delirium | Postoperative delirium was determined by CAM every day at 2st, 3st, 7st postoperative days | 2st, 3st, 7st postoperative days | 
| Postoperative Stroke | Postoperative Stroke will be determined by National Institutes of Health Stroke Scale (NIHSS) | 1st, 2st, 3st, 7st postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative delirium, Geriatric, General anesthesia, Propofol, Sevoflurane