Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2018-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to find out whether postoperative delirium can be more properly prevented by the combination of determined preventive agents in past studies. Further on the investigators measure pre- and postoperative cortisol, neuron specific enolase (NSE) and S-100beta levels.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

n-3 Enriched Nutrition Therapy and Postoperative Cognitive Dysfunction After Cardiac Surgery

NCT00757913

Delirium, Dementia, Amnestic, Cognitive Disorders Postoperative Cognitive Dysfunction

TERMINATED PHASE4

Predictors for Postoperative Delirium After Cardiac Surgery in Adults: a One-year, Single Center, Observational Cohort Study

NCT02613845

Postoperative Delirium

COMPLETED

Evaluation if Physostigmine Reduces Symptoms in Patients Who Has Developed a Delirium in Intensive Care After a Surgery

NCT02216266

Suspected Delirium After Elective or Emergency Heart Surgery CAM-ICU Diagnosed Delirium

UNKNOWN PHASE3

Pharmacological Management of Delirium

NCT00842608

Delirium Cognitive Impairment

COMPLETED NA

Decreasing the Incidence of Delirium After Cardiac Surgery

NCT02119806

C.Surgical Procedure; Cardiac Delirium

WITHDRAWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The postoperative delirium remains a challenge for medical stuff concerning detection, therapy and avoidance of consequences. Over the years numerous risk factors were detected which emphasizes the importance of its prevention. Within these studies some possibilities, but no strictly defined rules of action for pharmacological or neuropsychological prevention are described. This is why in this randomized, double-blinded, placebo-controlled study, the investigators want to compare two agents that were found to prevent postoperative delirium to a certain level, even in combination: the investigators arrange the patients within four study groups, one receiving Haloperidol, one Ketamine, one both and one placebo. The patients receive the study drug only once right before induction of anesthesia. After the day of recruitment there is the day of operation and a follow-up of three days (5 days of observation in total, where the investigators will test cognitive function with Mini Mental Status Examination (MMSE), Delirium Observation Scale (DOS), Nursing Delirium Screening Scale (Nu-DESC) or Intensive Care Delirium Screening Checklist (ICDSC). Additionally the investigators will measure and compare pre- and postoperative Cortisol, NSE and S-100beta levels.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Delirium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Haloperidol

Haloperidol 0.005mg/kg at induction of anesthesia

Group Type ACTIVE_COMPARATOR

Haloperidol

Intervention Type DRUG

Haloperidol 0.005mg/kg at induction of anesthesia

Ketamine

Ketamine 1mg/kg at induction of anesthesia

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Ketamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium

Haloperidol + Ketamine

Combination of Haloperidol + Ketamine in same dosage at induction of anesthesia

Group Type ACTIVE_COMPARATOR

Haloperidol + Ketamine

Intervention Type DRUG

Haloperidol 0.005mg/kg + Ketamine 1mg/kg at induction of anesthesia to test their power to prevent postoperative delirium if given together

Saline solution (NaCl 0.9%)

Placebo

Group Type PLACEBO_COMPARATOR

Saline solution (NaCl 0.9%)

Intervention Type DRUG

Placebo being used in one of the four groups

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Haloperidol

Haloperidol 0.005mg/kg at induction of anesthesia

Intervention Type DRUG

Ketamine

Ketamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium

Intervention Type DRUG

Haloperidol + Ketamine

Haloperidol 0.005mg/kg + Ketamine 1mg/kg at induction of anesthesia to test their power to prevent postoperative delirium if given together

Intervention Type DRUG

Saline solution (NaCl 0.9%)

Placebo being used in one of the four groups

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 65 years and older
* Signed agreement

Exclusion Criteria

* Delirium at admittance or MMSE score \<24 points
* High risk for postoperative ICU treatment
* Haloperidol or Ketamine intolerance
* Risk of lack of cooperation
* Drug an alcohol abuse
* Dementia
* QT interval (QTc) prolongation (at least 460ms in men, at least 470ms women) or drugs influencing QT interval, such as class Ia and III antiarrhythmics, Gatifloxacin, Moxifloxacin, Pentamidin, Cotrimoxazol, Tacrolimus, Dolasetron
* Parkinson's disease
* Intake of dopaminergic drugs (Levodopa, dopamine agonists)
* Parkinsonism
* Epilepsy
* Unable to be interviewed (severe Dementia, speaking disorders, intubation, respiratory isolation, aphasia, coma, terminal illness)
* Delay of operation of more than 72 hours past hospital admittance
* Body weight \>100kg

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes