Cardiovascular Safety After Continuous Ketamine Infusion

NCT ID: NCT03979105

Last Updated: 2019-06-07

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

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-12-31

Brief Summary

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Observational study that evaluate the cardiovascular and neuropsychiatric side effects of ketamine analgesic infusions for acute pain

Detailed Description

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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

Conditions

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Pain Ketamine Adverse Reaction Postoperative Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Ketamine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Ketalar

Eligibility Criteria

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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
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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Responsibility Role SPONSOR

Principal Investigators

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Adriana M Cadavid, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology Investigator

Locations

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hospital universitario San Vicente Fundacion

Medellín, Antioquia, Colombia

Site Status

Adriana Cadavid, MD

Medellín, Antiquia, Colombia

Site Status

Countries

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Colombia

References

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Avidan MS, Fritz BA, Maybrier HR, Muench MR, Escallier KE, Chen Y, Ben Abdallah A, Veselis RA, Hudetz JA, Pagel PS, Noh G, Pryor K, Kaiser H, Arya VK, Pong R, Jacobsohn E, Grocott HP, Choi S, Downey RJ, Inouye SK, Mashour GA. The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study: protocol for an international multicentre randomised controlled trial. BMJ Open. 2014 Sep 17;4(9):e005651. doi: 10.1136/bmjopen-2014-005651.

Reference Type BACKGROUND
PMID: 25231491 (View on PubMed)

Kase D, Imoto K. The Role of HCN Channels on Membrane Excitability in the Nervous System. J Signal Transduct. 2012;2012:619747. doi: 10.1155/2012/619747. Epub 2012 Aug 13.

Reference Type BACKGROUND
PMID: 22934165 (View on PubMed)

Pomeroy JL, Marmura MJ, Nahas SJ, Viscusi ER. Ketamine Infusions for Treatment Refractory Headache. Headache. 2017 Feb;57(2):276-282. doi: 10.1111/head.13013. Epub 2016 Dec 27.

Reference Type BACKGROUND
PMID: 28025837 (View on PubMed)

Sigtermans MJ, van Hilten JJ, Bauer MCR, Arbous SM, Marinus J, Sarton EY, Dahan A. Ketamine produces effective and long-term pain relief in patients with Complex Regional Pain Syndrome Type 1. Pain. 2009 Oct;145(3):304-311. doi: 10.1016/j.pain.2009.06.023. Epub 2009 Jul 14.

Reference Type BACKGROUND
PMID: 19604642 (View on PubMed)

Radvansky BM, Shah K, Parikh A, Sifonios AN, Le V, Eloy JD. Role of ketamine in acute postoperative pain management: a narrative review. Biomed Res Int. 2015;2015:749837. doi: 10.1155/2015/749837. Epub 2015 Oct 1.

Reference Type BACKGROUND
PMID: 26495312 (View on PubMed)

Garg N, Panda NB, Gandhi KA, Bhagat H, Batra YK, Grover VK, Chhabra R. Comparison of Small Dose Ketamine and Dexmedetomidine Infusion for Postoperative Analgesia in Spine Surgery--A Prospective Randomized Double-blind Placebo Controlled Study. J Neurosurg Anesthesiol. 2016 Jan;28(1):27-31. doi: 10.1097/ANA.0000000000000193.

Reference Type BACKGROUND
PMID: 26018671 (View on PubMed)

Assouline B, Tramer MR, Kreienbuhl L, Elia N. Benefit and harm of adding ketamine to an opioid in a patient-controlled analgesia device for the control of postoperative pain: systematic review and meta-analyses of randomized controlled trials with trial sequential analyses. Pain. 2016 Dec;157(12):2854-2864. doi: 10.1097/j.pain.0000000000000705.

Reference Type BACKGROUND
PMID: 27780181 (View on PubMed)

Cadavid AM, Casas FD, Camelo JE, Tovar A, Ramirez CD, Calle E, Visbal K. Effect of Analgesic Low-Dose Ketamine Infusions on the Cardiovascular Response: A Retrospective Analysis. Pain Physician. 2023 Sep;26(5):495-502.

Reference Type DERIVED
PMID: 37774188 (View on PubMed)

Other Identifiers

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UdeA1005

Identifier Type: -

Identifier Source: org_study_id

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