Effect of Bispectral Index (BIS) Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients

NCT ID: NCT01173263

Last Updated: 2014-03-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-03-31

Brief Summary

Eligible patients will be allocated to receive propofol sedation titrated to 3 different Bispectral Index (BIS) levels in a random order. Primary hypothesis: Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.

Detailed Description

Patient will be selected from the ICU, based on the defined inclusion and exclusion criteria. Potential study subjects will be screened by the research fellow or the on-site study co-investigator. Eligible patients will be allocated to receive propofol sedation titrated to 3 different BIS levels in a random order. BIS XP monitors (Aspect Medical Systems, Norwood, MA, USA) will be used which are relatively resistant to EMG artifact; a BIS sensor will be position on forehead of the patient after the skin is degreased and gently abraded. Esophageal pressure monitoring will be performed by a catheter inserted from the nose to the esophagus and left there trough the study period.

If patients are on sedation they will be placed on propofol sedation for a washout period. Each patient will receive propofol sedation by continuous infusion titrated to a different levels of BIS in a randomized fashion according to a computer-generated random-number sequence;

1. BIS levels of 70, will be targeted (Anxiolysis/high-frequency EEG activity, beta-augmentation);

2. BIS levels of 50 will be targeted, (Low frequency EEG activity, theta-delta activity);

3. BIS levels of 35 will be targeted (low frequency EEG activity). A propofol infusion will be titrated by the investigators to the designated BIS target according to randomization. Clinical personnel will not be blinded to the study, and if patient has clinically significant change in hemodynamic parameters study will be interrupted. Each BIS target level will be kept as constant as possible for at least one hour; thereafter, lower esophageal pressures will be recorded for 15 minutes using high resolution esophageal manometry. Studies will be done in supine position [Most ICU patients are now kept head-up.], and the manometric assembly will be positioned to record from the hypopharynx to the stomach with 4-6 of the sensors positioned in the stomach.

All patients will otherwise receive routine ICU care and medications without interruption of standard clinical care.

Conditions

Respiration, Artificial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

BIS 70

BIS levels of 70, will be targeted (Anxiolysis/high-frequency EEG activity, beta-augmentation);

Group Type: ACTIVE_COMPARATOR

BIS 70 maintained

Intervention Type: OTHER

Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 70.

BIS 50

BIS levels of 50 will be targeted, (Low frequency EEG activity, theta-delta activity)

Group Type: ACTIVE_COMPARATOR

BIS level 50

Intervention Type: OTHER

Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 50.

BIS 35

BIS levels of 35 will be targeted (low frequency EEG activity)

Group Type: ACTIVE_COMPARATOR

BIS 35

Intervention Type: OTHER

Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 35.

Interventions

BIS 70 maintained

Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 70.

Intervention Type: OTHER

BIS level 50

Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 50.

Intervention Type: OTHER

BIS 35

Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 35.

Intervention Type: OTHER

Other Intervention Names

sedation; propofol; BIS monitor; esophageal pressure; esophageal function; sedation; propofol; BIS monitor; esophageal pressure; esophageal function; sedation; propofol; BIS monitor; esophageal pressure; esophageal function

Eligibility Criteria

Inclusion Criteria

• 18-80 years of age
• Written informed consent from relatives
• Clinically stable
• Mechanically ventilated < 2days
• Require sedation and expected to be given propofol

Exclusion Criteria

• Recent injury or other pathologic condition of the esophagus
• Major bronchopleural fistula
• History of liver failure
• History of renal failure
• History of major neuromuscular disease
• Multiple trauma
• Upper motor nerve injury
• Hypersensitivity to propofol
• Recent gastrointestinal surgery
• Patients with a diagnosed or suspected condition that may give false results in BIS monitoring.
• Tracheostomized patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Alparslan Turan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alparslan Turan, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

10-226

Identifier Type: -

Identifier Source: org_study_id