Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions

Not Applicable

Completed

• Conditions: Pain, Postoperative; Ketamine Adverse Reaction
• Interventions: Drug: Ketamine

• Registration Number: NCT03525912
• Lead Sponsor: Universidad de Antioquia

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-03-31
• Study First Submitted: 2018-04-21
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-16
• Study Completion: 2018-11-14
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• patient scheduled for abdominal, thoracic or orthopedic surgery

Exclusion Criteria

cognitive disfunction psychiatric illness cardiovascular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketamine infusion	Ketamine	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.

Primary Outcome Measures

Name	Time	Method
Delirium	2 days	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.

Secondary Outcome Measures

Name	Time	Method
Sedation	24 and 48 hours postoperatively	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)
Agitation	24 and 48 hours postoperatively	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)

Trial Locations

Locations (1)

hospital universitario San Vicente Fundacion; 🇨🇴 Medellin, Antioquia, Colombia