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Trial record 4 of 852 for:    Ketamine

Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03525912
Recruitment Status : Completed
First Posted : May 16, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Adriana Margarita Cadavid, Universidad de Antioquia

Brief Summary:
Evaluation of neuropsychiatric and cardiovascular side effects of low dose ketamine analgesic infusion for postoperative pain

Condition or disease Intervention/treatment Phase
Pain, Postoperative Ketamine Adverse Reaction Drug: Ketamine Not Applicable

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.


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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
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.
Drug: Ketamine
continuous infusion of low dose ketamine for postoperative pain
Other Name: analgesic ketamine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)


Other Outcome Measures:
  1. Hallucinations [ Time Frame: 24 and 48 hours postoperatively ]
    Presence or absence of hallucinations

  2. Bad Dreams [ Time Frame: 24 and 48 hours postoperatively ]
    Presence or absence of bad dreams

  3. Hypertension [ Time Frame: 0, 24 and 48 hours postoperatively ]
    Hypertension is defined as a systolic blood pressure (SBP) of 140 mm Hg or more

  4. Tachycardia [ Time Frame: 0, 24 and 48 hours postoperatively ]
    a heart rate of more than 100 beats per minute (BPM)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- patient scheduled for abdominal, thoracic or orthopedic surgery

Exclusion Criteria:

cognitive disfunction psychiatric illness cardiovascular disease


Information from the National Library of Medicine

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


Locations
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Colombia
hospital universitario San Vicente Fundacion
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Universidad de Antioquia
Investigators
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Principal Investigator: Adriana M Cadavid, MD Anesthesiology professor

Publications:
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Responsible Party: Adriana Margarita Cadavid, Professor, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT03525912     History of Changes
Other Study ID Numbers: UdeA1002
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ketamine
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action