Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01618396

Enrollment

Registered

2012-06-13

Start date

2011-03-31

Completion date

2011-08-31

Last updated

2012-06-13

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

Conditions

Sepsis, Shock,

Keywords

Microcirculation, Hypnotics and Sedatives,, Propofol,, Midazolam

Brief summary

Previous studies have demonstrated that altered microvascular blood flow is an important marker of severe sepsis. Usually, these patients need invasive ventilatory support, frequent use of sedatives and it is unknown if these agents interfere or not on microvascular blood flow. The goal of this study was to compare effects of propofol and midazolam infusions on sublingual microcirculation of septic shock patients.

Interventions

DRUGSedation drug (Propofol and Midazolam)

Septic patients, after intubation, were initially sedated with propofol. During the second day of mechanical ventilation, propofol infusion was interrupted. When the patient awoke, the sedative drug was changed to midazolam. Sedation target was a Ramsay Scale score of 4 to 5.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Septic shock patients needing mechanical ventilation in pressure or volume-controlled mode.

Exclusion criteria

* age less than 18 years, * pregnancy, * non-sinus rhythm, and * contraindication of daily interruption of sedative drug, * mainly with the use of neuromuscular blocking drugs, or * patients with intracranial hypertension or epileptical status.

Design outcomes

Primary

Measure	Time frame	Description
Sublingual Microcirculatory Variables	Just before stopping propofol and thirty minutes after the start of midazolam infusion	Patients were sedated with propofol during the first 24 hours after intubation and with midazolam afterwards.Systemic hemodynamics and perfusion parameters were assessed at two time points: just before stopping propofol and thirty minutes after the start of midazolam infusion. At both steps, four microcirculatory sequences were acquired using sidestream darkfield imaging to access sublingual microcirculation

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026