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Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions

Primary Purpose

Pain, Postoperative, Ketamine Adverse Reaction

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Ketamine
Sponsored by
Universidad de Antioquia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- patient scheduled for abdominal, thoracic or orthopedic surgery

Exclusion Criteria:

cognitive disfunction psychiatric illness cardiovascular disease

Sites / Locations

  • hospital universitario San Vicente Fundacion

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketamine infusion

Arm Description

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.

Outcomes

Primary Outcome Measures

Delirium
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

Agitation
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
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)

Full Information

First Posted
April 21, 2018
Last Updated
March 27, 2019
Sponsor
Universidad de Antioquia
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1. Study Identification

Unique Protocol Identification Number
NCT03525912
Brief Title
Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions
Official Title
Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
November 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Antioquia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Ketamine Adverse Reaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single group assignment interventional
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine infusion
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
analgesic ketamine
Intervention Description
continuous infusion of low dose ketamine for postoperative pain
Primary Outcome Measure Information:
Title
Delirium
Description
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.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Agitation
Description
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)
Time Frame
24 and 48 hours postoperatively
Title
Sedation
Description
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)
Time Frame
24 and 48 hours postoperatively
Other Pre-specified Outcome Measures:
Title
Hallucinations
Description
Presence or absence of hallucinations
Time Frame
24 and 48 hours postoperatively
Title
Bad Dreams
Description
Presence or absence of bad dreams
Time Frame
24 and 48 hours postoperatively
Title
Hypertension
Description
Hypertension is defined as a systolic blood pressure (SBP) of 140 mm Hg or more
Time Frame
0, 24 and 48 hours postoperatively
Title
Tachycardia
Description
a heart rate of more than 100 beats per minute (BPM)
Time Frame
0, 24 and 48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - patient scheduled for abdominal, thoracic or orthopedic surgery Exclusion Criteria: cognitive disfunction psychiatric illness cardiovascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana M Cadavid, MD
Organizational Affiliation
Anesthesiology professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
hospital universitario San Vicente Fundacion
City
Medellin
State/Province
Antioquia
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27275042
Citation
Gorlin AW, Rosenfeld DM, Ramakrishna H. Intravenous sub-anesthetic ketamine for perioperative analgesia. J Anaesthesiol Clin Pharmacol. 2016 Apr-Jun;32(2):160-7. doi: 10.4103/0970-9185.182085.
Results Reference
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PubMed Identifier
21773855
Citation
Laskowski K, Stirling A, McKay WP, Lim HJ. A systematic review of intravenous ketamine for postoperative analgesia. Can J Anaesth. 2011 Oct;58(10):911-23. doi: 10.1007/s12630-011-9560-0. Epub 2011 Jul 20.
Results Reference
background
PubMed Identifier
27965560
Citation
Li L, Vlisides PE. Ketamine: 50 Years of Modulating the Mind. Front Hum Neurosci. 2016 Nov 29;10:612. doi: 10.3389/fnhum.2016.00612. eCollection 2016.
Results Reference
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Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions

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