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Effect of Sedation on Intra-abdominal Pressure

NCT02944292 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-12-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of deepening of sedation on intra-abdominal pressure in mechanically ventilated adult patients with intra-abdominal hypertension.

Conditions

  • Intra-abdominal Hypertension

Interventions

PROCEDURE

Deepening of sedation

Deepening of sedation will be achieved with a bolus and subsequent continuous infusion of propofol.

DRUG

Propofol

Propofol will be dosed according to lean body weight (LBW) for bolus administration and according to total body weight (TBW) for continuous infusion. All patients will receive a bolus of propofol 1 mg/kg LBW as a rapid infusion during one minute. Measurements will be made one minute after the ending of bolus infusion. Continuous infusion of propofol at a rate of 3 mg/kg/h will be started immediately following completion of measurements, not later than 5 minutes after bolus administration. The propofol infusion rate is decreased in case of hemodynamic instability by 1 mg/kg/h and until a minimum of 1 mg/kg/h, if needed. Maximum total dose of infusion of 5 mg/kg/h will not be exceeded (bolus not considered).

Sponsors & Collaborators

  • Tartu University Hospital

    lead OTHER

Principal Investigators

  • Joel Starkopf, MD PhD · Tartu University Hospital; University of Tartu

  • Annika Reintam Blaser, MD PhD · University of Tartu

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Estonia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02944292 on ClinicalTrials.gov