Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions

Study Overview
=================
Brief Summary
-----------------
Evaluation of neuropsychiatric and cardiovascular side effects of low dose ketamine analgesic infusion for postoperative pain

Detailed Description
-----------------
Postoperative pain is a world wide problem related with surgery. Multimodal analgesia may include ketamine, aimed to decrease opioid adverse effects in postoperative analgesia for major surgery, and risk of chronic postsurgical pain. Ketamine has shown efficacy as adjuvant in multimodal analgesia, however, neuropsychiatric and cardiovascular effects of ketamine at low doses in continue postoperative infusion are less known. This type of adverse effects may compromise appropriated recovery. Objective to determine frequency of delirium, agitation, sedation, hallucinations, bad dreams and cardiovascular changes associated with ketamine analgesic infusion treatment for postoperative pain.

Official Title
-----------------
Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions: a Prospective Study

Conditions
-----------------
Pain, Postoperative, Ketamine Adverse Reaction

Intervention / Treatment
-----------------
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patient scheduled for abdominal, thoracic or orthopedic surgery Exclusion Criteria: cognitive disfunction psychiatric illness cardiovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single group assignment interventional
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine infusion<br>postoperative pain in adult population after abdominal, thoracic and orthopedic surgery that received adjuvant analgesia with ketamine 0.1mg/kg/h during 24 to 48 hours in postoperative period. | Drug: Ketamine<br>* continuous infusion of low dose ketamine for postoperative pain<br>* Other names: analgesic ketamine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium | Presence or absence of delirium at 24 and 48 hours postoperatively over the past 2 days of exposure to ketamine infusion, using the Confusion Assessment Method (CAM), a clinical based assessment tool for identifying delirium. Consist of 4 criteria ( timing of symptoms, attention, thinking, consciousness). Considered to be positive for delirium if both features 1 and 2 are present, with at least one of features 3 or 4. | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agitation | Richmond Agitation- Sedation Scale (RASS) score is a 10 point scale with discrete criteria, with four levels of agitation (+1 to +4), one level for calm and alert state (0), and 5 levels of sedation (-1 to -5) | 24 and 48 hours postoperatively | 
| Sedation | Clinician based Richmond Agitation- Sedation Scale (RASS) at 24 and 48 hours. RASS is a 10 point scale with discrete criteria, with four levels of agitation (+1 to +4), one level for calm and alert state (0), and 5 levels of sedation (-1 to -5) | 24 and 48 hours postoperatively |