Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions
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|ClinicalTrials.gov Identifier: NCT03525912|
Recruitment Status : Completed
First Posted : May 16, 2018
Last Update Posted : March 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative Ketamine Adverse Reaction||Drug: Ketamine||Not Applicable|
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.
to determine frequency of delirium, agitation, sedation, hallucinations, bad dreams and cardiovascular changes associated with ketamine analgesic infusion treatment for postoperative pain.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single group assignment interventional|
|Masking:||None (Open Label)|
|Official Title:||Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions: a Prospective Study|
|Actual Study Start Date :||July 1, 2017|
|Actual Primary Completion Date :||March 31, 2018|
|Actual Study Completion Date :||November 14, 2018|
Experimental: Ketamine infusion
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.
continuous infusion of low dose ketamine for postoperative pain
Other Name: analgesic ketamine
- Delirium [ Time Frame: 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.
- Agitation [ Time Frame: 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 [ Time Frame: 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)
- Hallucinations [ Time Frame: 24 and 48 hours postoperatively ]Presence or absence of hallucinations
- Bad Dreams [ Time Frame: 24 and 48 hours postoperatively ]Presence or absence of bad dreams
- Hypertension [ Time Frame: 0, 24 and 48 hours postoperatively ]Hypertension is defined as a systolic blood pressure (SBP) of 140 mm Hg or more
- Tachycardia [ Time Frame: 0, 24 and 48 hours postoperatively ]a heart rate of more than 100 beats per minute (BPM)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525912
|hospital universitario San Vicente Fundacion|
|Medellin, Antioquia, Colombia|
|Principal Investigator:||Adriana M Cadavid, MD||Anesthesiology professor|