Cardiovascular Safety After Continuous Ketamine Infusion

NCT03979105 | Completed DMC

• 1 other identifier: UdeA1005
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pain; Ketamine Adverse Reaction; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Tachycardia

  Presence of absence of tachycardia (100 or above beats for minute) as physiological parameter recorded with cardioscope in the first 48 hours in clinical chart database after the infusion of ketamine has started.

  2 days

• Hypertension

  Presence or absence of hypertension (140/90 mm Hg or above ) as physiological parameter recorded with electronic arm manometer in the first 48 hours in clinical chart database after the infusion of ketamine has started.

  2 days

Secondary Outcomes (3)

• Delirium

  2 days

• Hallucinations

  2 days

• Nightmares

  2 days

Study Arms (1)

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.

Drug: Ketamine

Interventions

Ketamine 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

Also known as: Ketalar

Ketamine infusion

Eligibility Criteria

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

Study Population

Adults with acute pain after surgery or medical painful condition

You may qualify if:

• Patients older than 18 years old
• Acute and Postoperative pain
• Ketamine infusion at 0.15 mg/kg/h or below

You may not qualify if:

• Cognitive disfunction psychiatric illness
• Acute cardiovascular disease
• Anemia with Hb less than 7 g/dl
• Decompensated hyperthyroidism
• Low cardiac output
• Incomplete medical history

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (2)

hospital universitario San Vicente Fundacion

Medellín, Antioquia, Colombia

Location

Adriana Cadavid, MD

Medellín, Antiquia, 050010, Colombia

Location

Related Publications (8)

• 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.

  PMID: 25231491 BACKGROUND

• 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.

  PMID: 22934165 BACKGROUND

• 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.

  PMID: 28025837 BACKGROUND

• 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.

  PMID: 19604642 BACKGROUND

• 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.

  PMID: 26495312 BACKGROUND

• 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.

  PMID: 26018671 BACKGROUND

• 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.

  PMID: 27780181 BACKGROUND

• 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.

  PMID: 37774188 DERIVED

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Adriana M Cadavid, MD

  Anesthesiology Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: June 7, 2019
• Study Start: July 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 31, 2018
• Last Updated: June 7, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)