Ketamine effects on Brain Monitoring and Sedation Levels

Phase 4

• Conditions: Ketamine; Electroencephalography; E03.250

• Registration Number: RBR-5cqxrrx
• Lead Sponsor: Hospital São Carlos

Brief Summary

Ketamine s (+) plays an important role in pain modulation in surgical patients. However, its intraoperative use may not validate the anesthetic adequacy indexes based on the electroencephalogram. This work aims to evaluate the relationship between levels of sedation, produced by low doses of ketamine s (+), as well as electroencephalographic variables: PSI, electromyography (EMG) and suppression rate. Thirty adult patients, both sexes, aged between 22 and 46 years were randomly assigned to 3 groups. In group G1 (10) received ketamine s (+) at a dose of 0.050 mg.kg-1 i.v.; in the G2 group (10) received ketamine s (+) at a dose of 0.125 mg.kg-1 i.v. and in the G3 group (10) received ketamine s (+) at a dose of 0.250 mg.kg-1 i.v. In all groups, patients received 0.08 mg.kg-1 midazolam i.v. 10 minutes before administration of s(+) ketamine. Two moments were evaluated in each group: M1: before administration of s (+) ketamine and M2: after administration of s (+) ketamine. In all groups, the level of sedation was evaluated, as well as the electroencephalographic variables: PSI, EMG and suppression rate, before and after the injection of s (+) ketamine. The electroencephalographic data obtained were analyzed using ANOVA for repeated measures and adjusted p-value for multiple comparisons by Tukey's test. There was a dose dependent decrease in sedation alert scale scores in all groups at M2 time points. Electroencephalographic analysis showed statistically significant variations in all groups, comparing moments M1 and M2 both in EMG and PSI (p<0.05). Sedation levels significantly correlate with increasing dose of s(+) ketamine. However, the high PSI values ??may be the result of both increases in the electrical activity of the brain cortex and the electromyographic activity induced by s(+) ketamine, and this index should be used with caution

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-29
• Study Start: 2022-12-21
• 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; both genders; age between 22 and 46 years; body mass index between 22 and 26 kg.m-2

Exclusion Criteria

Use of drugs that affect electroencephalographic activity

Study & Design

• Study Type: Intervention
• Study Design: Not specified