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Trial record 1 of 840 for:    Ketamine
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Cardiovascular Safety After Continuous Ketamine Infusion

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ClinicalTrials.gov Identifier: NCT03979105
Recruitment Status : Completed
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Universidad de Antioquia

Brief Summary:
Observational study that evaluate the cardiovascular and neuropsychiatric side effects of ketamine analgesic infusions for acute pain

Condition or disease Intervention/treatment
Pain Ketamine Adverse Reaction Postoperative Pain Drug: Ketamine

Detailed Description:

Severe acute pain and opioid tolerance is an important symptom in patients after surgery.

Ketamine in analgesic infusion has been described to decrease acute pain, in patients with opioid tolerance. Ketamine use has been associated with side effects, which are doses dependant. Those side effects are mainly cardiovascular: Hypertension, tachycardia, and neuropsychiatric: delirium, hallucinations,nightmares that potentially compromise recovery of patients.

Objective:

To determine retrospectively in data bases the frequency of tachycardia, hypertension, delirium, hallucinations and nightmares, in adult patients that received ketamine infusions before and after administration of this drug in the first 48 hours to treat acute and postoperative pain


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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cardiovascular and Neuropsychiatric Side Effects in Ketamine Analgesic Infusions in Acute Pain
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Group/Cohort Intervention/treatment
Ketamine infusion
Ketamine infusion treatment for acute pain in adult population in all type of surgery that received adjuvant analgesia with ketamine 0.1mg/kg/h during 48 hours.
Drug: Ketamine
Drug: Ketamine Side effects associated with ketamine infusion to treat acute pain, were reviewed after 48 hours of exposure and frequency of tachycardia, hypertension, hallucinations, delirium and nightmares were registrated for comparison
Other Name: Ketalar




Primary Outcome Measures :
  1. Tachycardia [ Time Frame: 2 days ]
    Presence of absence of tachycardia (100 or above beats for minute) as physiological parameter recorded with cardioscope in the first 48 hours in clinical chart database after the infusion of ketamine has started.

  2. Hypertension [ Time Frame: 2 days ]
    Presence or absence of hypertension (140/90 mm Hg or above ) as physiological parameter recorded with electronic arm manometer in the first 48 hours in clinical chart database after the infusion of ketamine has started.


Secondary Outcome Measures :
  1. Delirium [ Time Frame: 2 days ]
    Presence of absence of delirium reported in clinical records electronic database by nurse or physician in the first 48 hours after the infusion of ketamine has started.

  2. Hallucinations [ Time Frame: 2 days ]
    Presence of absence hallucinations reported in clinical electronic database records by nurse or physician in the first 48 hours after the infusion of ketamine has started.

  3. Nightmares [ Time Frame: 2 days ]
    Presence of absence of nightmares reported in clinical electronic database records by nurse or physician, in the first 48 hours after the infusion of ketamine has started.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with acute pain after surgery or medical painful condition
Criteria

Inclusion Criteria:

  • Patients older than 18 years old
  • Acute and Postoperative pain
  • Ketamine infusion at 0.15 mg/kg/h or below

Exclusion Criteria:

  • Cognitive disfunction psychiatric illness
  • Acute cardiovascular disease
  • Anemia with Hb less than 7 g/dl
  • Decompensated hyperthyroidism
  • Low cardiac output
  • Incomplete medical history

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): NCT03979105


Locations
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Colombia
hospital universitario San Vicente Fundacion
Medellin, Antioquia, Colombia
Adriana Cadavid, MD
Medellín, Antiquia, Colombia, 050010
Sponsors and Collaborators
Universidad de Antioquia
Investigators
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Principal Investigator: Adriana M Cadavid, MD Anesthesiology Investigator

Publications:

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Responsible Party: Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT03979105     History of Changes
Other Study ID Numbers: UdeA1005
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: April 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