Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions

NCT ID: NCT03525912

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-11-14

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain, Postoperative Ketamine Adverse Reaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single group assignment interventional
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

continuous infusion of low dose ketamine for postoperative pain

Interventions

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Ketamine

continuous infusion of low dose ketamine for postoperative pain

Intervention Type DRUG

Other Intervention Names

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analgesic ketamine

Eligibility Criteria

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Inclusion Criteria

\- patient scheduled for abdominal, thoracic or orthopedic surgery

Exclusion Criteria

cognitive disfunction psychiatric illness cardiovascular disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Antioquia

OTHER

Sponsor Role lead

Responsible Party

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Adriana Margarita Cadavid

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adriana M Cadavid, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology professor

Locations

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hospital universitario San Vicente Fundacion

MedellĂ­n, Antioquia, Colombia

Site Status

Countries

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Colombia

References

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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.

Reference Type BACKGROUND
PMID: 27275042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21773855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27965560 (View on PubMed)

Other Identifiers

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UdeA1002

Identifier Type: -

Identifier Source: org_study_id

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