Influence of low-doses Dextroketamine on Brain Monitoring

Phase 4

• Conditions: Ketamine; Electroencephalography; E03.155

• Registration Number: RBR-4vdpqrt
• Lead Sponsor: Hospital São Carlos

Brief Summary

Introduction and objectives: S (+) ketamine (CS) plays an important role in pain modulation in surgical patients. However, several studies show significant increases in electroencephalographic activity (EEG) when s (+) ketamine is used. Suppression Rate (TS), a time-domain EEG variable, is important to determine cerebral perfusion. The aim of this study is to evaluate changes in TS with the use of low doses of S-ketamine. Methods: A triple-blind clinical trial was conducted with 20 patients, both genders, with 20 to 50 terás old, who underwent elective surgeries under general anesthesia, with BIS between 45 to 60 to tracheal intubation, then the dose of propofol was increased until a SR between 10% and 20% was obtained. Patients were randomly allocated into two groups, CG (control: 0.9% saline) and CGS (s-ketamine: 0.2 mg.kg-1). Each group was assessed at M0 (immediately before pre-oxygenation), M1 (3 minutes after SR stabilization) and M2 (3 minutes after infusion of s-ketamine or 0.9% saline). The obtained EEG data were analyzed using ANOVA, comparing both between moments in the same group and between groups at equivalent moments, considering a p=0.05 as significant. Results: There were no statistically significant changes regarding SR from M1 to M2. There was also no indication of a significant difference between the average SR values concerning the factors group and moments (p>0,05). Conclusions: Low doses of s-ketamine (0,2 mg.kg-1) in TIVA model, were insufficient to determine changes in SR values, validating this important electroencephalographic parameter

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-30
• Study Start: 2023-03-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Volunteers with physical status P1 (American Society of Anesthesiologists); both genders; age between 20 and 50 years; body mass index between 21 and 26kg.m-2

Exclusion Criteria

Recent use of drugs that alter the electroencephalogram

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expectaded outcome 1: It is expected to find changes in the values of the suppression rate and bispectral index after infusion of low doses of dextroketamine, verified through the processed electroencephalogram, from the observation of a pre- and post-intervention variation with statistical significance of p=0, 05;Finding 1: There were no statistically significant changes regarding supression rate. There was also no indication of a significant difference between the average supression rate values concerning the factors group and moment

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes were not expected