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Sevoflurane vs Propofol for Postoperative Delirium in Geriatric Patients

NCT01995214Phase 4

Key facts

Status: Unknown
Start: Jun 2013
Primary completion: Dec 2013
Countries: 1
Sponsor: Huazhong University of Science and Technology
Modality: Small Molecules

Drugs: propofol
Conditions: postoperative delirium (POD)

Overview

Phase 4, randomised trial of propofol in postoperative delirium (POD) (2 arms), sponsored by Huazhong University of Science and Technology. Primary endpoint: Incidence of Postoperative Delirium at 24 hours. Status: unknown.

Design

2 arms

Study design: Randomized

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

Who it enrols

Geriatric patients (>= 60 years) with ASA PS class I-III undergoing elective major surgery under general anesthesia, excluding those with BMI > 30, neurologic disease, undergoing cardiac or neurologic surgery, or taking anticonvulsants or chronic analgesics.

Endpoints

Primary

Incidence of Postoperative Delirium24 hours

Secondary

Length of postanesthesia care unit (PACU) stayup to 2 hours
Hemodynamic parameters30 min before incision closure
Incidence of postoperative nausea and vomiting24 hours
Quality of recovery score7 days
Incidence of Postoperative Delirium at later timepoints7 days
Incidence of Postoperative Stroke7 days

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