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Completed

NCT Number: NCT03525912

Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions

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

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Key information

Conditions

Pain, Postoperative Ketamine Adverse Reaction Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

hospital universitario San Vicente Fundacion

Medellín, Antioquia, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient scheduled for abdominal, thoracic or orthopedic surgery

Exclusion criteria

cognitive disfunction psychiatric illness cardiovascular disease

Treatment and study plan

ketamine

Drug

continuous infusion of low dose ketamine for postoperative pain

Other names: analgesic ketamine

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 16, 2018
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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