Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions

Pain, Postoperative Clinical Trial

Official title:

Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525912
• Other study ID #: UdeA1002
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: November 14, 2018

Study information

• Verified date: March 2019
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 14, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient scheduled for abdominal, thoracic or orthopedic surgery

Exclusion Criteria:

cognitive disfunction psychiatric illness cardiovascular disease

Related Conditions & MeSH terms

• Ketamine Adverse Reaction
• Pain, Postoperative

Intervention

Drug:
• Ketamine
continuous infusion of low dose ketamine for postoperative pain

Locations

Country	Name	City	State
Colombia	hospital universitario San Vicente Fundacion	Medellin	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

References & 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. Review. — View 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. Review. — View Citation

Li L, Vlisides PE. Ketamine: 50 Years of Modulating the Mind. Front Hum Neurosci. 2016 Nov 29;10:612. eCollection 2016. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hallucinations	Presence or absence of hallucinations	24 and 48 hours postoperatively
Other	Bad Dreams	Presence or absence of bad dreams	24 and 48 hours postoperatively
Other	Hypertension	Hypertension is defined as a systolic blood pressure (SBP) of 140 mm Hg or more	0, 24 and 48 hours postoperatively
Other	Tachycardia	a heart rate of more than 100 beats per minute (BPM)	0, 24 and 48 hours postoperatively
Primary	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	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)	24 and 48 hours postoperatively
Secondary	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)	24 and 48 hours postoperatively