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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

Tracking Information
First Submitted Date  ICMJE April 21, 2018
First Posted Date  ICMJE May 16, 2018
Last Update Posted Date March 28, 2019
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2018)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 14, 2018)
  • 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions
Official Title  ICMJE Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions: a Prospective Study
Brief Summary Evaluation of neuropsychiatric and cardiovascular side effects of low dose ketamine analgesic infusion for postoperative pain
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
single group assignment interventional
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Postoperative
  • Ketamine Adverse Reaction
Intervention  ICMJE Drug: Ketamine
continuous infusion of low dose ketamine for postoperative pain
Other Name: analgesic ketamine
Study Arms  ICMJE 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.
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2019)		 101
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2018)		 240
Actual Study Completion Date  ICMJE November 14, 2018
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- patient scheduled for abdominal, thoracic or orthopedic surgery

Exclusion Criteria:

cognitive disfunction psychiatric illness cardiovascular disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03525912
Other Study ID Numbers  ICMJE UdeA1002
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  ICMJE
Plan to Share IPD: No
Current Responsible Party Adriana Margarita Cadavid, Universidad de Antioquia
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Universidad de Antioquia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adriana M Cadavid, MD Anesthesiology professor
PRS Account Universidad de Antioquia
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP