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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

Tracking Information
First Submitted Date April 4, 2019
First Posted Date June 7, 2019
Last Update Posted Date June 7, 2019
Actual Study Start Date July 1, 2017
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 6, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiovascular Safety After Continuous Ketamine Infusion
Official Title Cardiovascular and Neuropsychiatric Side Effects in Ketamine Analgesic Infusions in Acute Pain
Brief Summary Observational study that evaluate the cardiovascular and neuropsychiatric side effects of ketamine analgesic infusions for acute pain
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

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with acute pain after surgery or medical painful condition
Condition
  • Pain
  • Ketamine Adverse Reaction
  • Postoperative Pain
Intervention 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
Study Groups/Cohorts 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.
Intervention: Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 6, 2019)
300
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Colombia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03979105
Other Study ID Numbers UdeA1005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Universidad de Antioquia
Study Sponsor Universidad de Antioquia
Collaborators Not Provided
Investigators
Principal Investigator: Adriana M Cadavid, MD Anesthesiology Investigator
PRS Account Universidad de Antioquia
Verification Date April 2019