Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions

NCT03525912 | Completed DMC

• 1 other identifier: UdeA1002
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative; Ketamine Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• 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.

  2 days

Secondary Outcomes (2)

• Agitation

  24 and 48 hours postoperatively

• Sedation

  24 and 48 hours postoperatively

Other Outcomes (4)

• Hallucinations

  24 and 48 hours postoperatively

• Bad Dreams

  24 and 48 hours postoperatively

• Hypertension

  0, 24 and 48 hours postoperatively

Study Arms (1)

Ketamine infusion

EXPERIMENTAL

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.

Drug: Ketamine

Interventions

Ketamine DRUG

continuous infusion of low dose ketamine for postoperative pain

Also known as: analgesic ketamine

Ketamine infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- patient scheduled for abdominal, thoracic or orthopedic surgery

You may not qualify if:

• cognitive disfunction psychiatric illness cardiovascular disease

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

hospital universitario San Vicente Fundacion

Medellín, Antioquia, Colombia

Location

Related Publications (3)

• 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.

  PMID: 27275042 BACKGROUND

• 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.

  PMID: 21773855 BACKGROUND

• 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.

  PMID: 27965560 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Adriana M Cadavid, MD

  Anesthesiology professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: single group assignment interventional

Study Record Dates

• First Submitted: April 21, 2018
• First Posted: May 16, 2018
• Study Start: July 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: November 14, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)