Ketamine Adverse Reaction, Pain, Postoperative
Conditions
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.
Interventions
DRUGKetamine
continuous infusion of low dose ketamine for postoperative pain
Sponsors
Universidad de Antioquia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single group assignment interventional
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- patient scheduled for abdominal, thoracic or orthopedic surgery
Exclusion criteria
cognitive disfunction psychiatric illness cardiovascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delirium | 2 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agitation | 24 and 48 hours postoperatively | 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) |
| Sedation | 24 and 48 hours postoperatively | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hallucinations | 24 and 48 hours postoperatively | Presence or absence of hallucinations |
| Tachycardia | 0, 24 and 48 hours postoperatively | a heart rate of more than 100 beats per minute (BPM) |
| Bad Dreams | 24 and 48 hours postoperatively | Presence or absence of bad dreams |
| Hypertension | 0, 24 and 48 hours postoperatively | Hypertension is defined as a systolic blood pressure (SBP) of 140 mm Hg or more |
Countries
Colombia
Outcome results
None listed