Ketamine effects on Brain Monitoring and Sedation Levels

Effects of Ketamine s (+) on PSI-SEDLine Electroencephalogram and Sedation Levels

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-5cqxrrx

Enrollment

Unknown

Registered

2022-12-21

Start date

2022-08-15

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ketamine

Interventions

This is a three-arm, open-label, randomized controlled clinical trial. Thirty adult patients of both genders will participate in the study, with ages ranging from 22 to 46 years, physical status P1, i

E03.155

Q000008

Eligibility

Age

22 Years to 46 Years

Inclusion criteria

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

Exclusion criteria: Use of drugs that affect electroencephalographic activity

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: It is expected to find a positive correlation between the levels of sedation produced by the administration of low doses of ketamine s (+) and the value evidenced by the use of monitoring of electroencephalographic variables, verified through the processed electroencephalogram, electromyography and suppression rate, from the finding of a variation in the pre and post-intervention measurement with statistical significance of p<0,05;Outcome 1: The results showed a decrease, dose dependent, in the scores of the sedation alert scale in all groups, after ketamine s (+)- p<0.05, when comparing the intragroup moments (G1, G2 and G3 ). Significant increases in electromyographic power were observed with increasing doses of s(+) ketamine in all groups (p<0.05) and PSI values, after administration of s(+) ketamine, increased by all groups in M2 –p<0.05. No burst-suppression episodes were observed	—

Measure

Time frame

Expected outcome 1: It is expected to find a positive correlation between the levels of sedation produced by the administration of low doses of ketamine s (+) and the value evidenced by the use of monitoring of electroencephalographic variables, verified through the processed electroencephalogram, electromyography and suppression rate, from the finding of a variation in the pre and post-intervention measurement with statistical significance of p<0,05;Outcome 1: The results showed a decrease, dose dependent, in the scores of the sedation alert scale in all groups, after ketamine s (+)- p<0.05, when comparing the intragroup moments (G1, G2 and G3 ). Significant increases in electromyographic power were observed with increasing doses of s(+) ketamine in all groups (p<0.05) and PSI values, after administration of s(+) ketamine, increased by all groups in M2 –p<0.05. No burst-suppression episodes were observed

—

Secondary

Measure	Time frame
Secondary outcomes are not expected	—

Countries

Brazil

Contacts

Public ContactDaniel Nobre

Hospital São Carlos

danielgmnobre@gmail.com+55(85)4009-1278

Outcome results

None listed

Source: REBEC (via WHO ICTRP)