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

This study has been terminated.
(recruitment difficulties)
Sponsor:
Information provided by (Responsible Party):
Alparslan Turan, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01173263
First received: July 21, 2010
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Respiration, Artificial
Other: BIS 70 maintained
Other: BIS level 50
Other: BIS 35

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of BIS Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Deepening propofol sedation — as determined by BIS — lowers esophageal pressure in critical care patients. [ Time Frame: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU ] [ Designated as safety issue: No ]
    Sedation will also be evaluated with the bispectral index of the electroencephalogram. BIS of the EEG data will be acquired with 4 BIS-sensor electrodes and a BIS XP monitor. The BIS will be recorded electronically at one-minute intervals. Heart rate, blood pressures (diastolic and systolic), respiratory rate, core temperature and oxygen saturation will be recorded every 5 minutes during the measurement period of the study.


Secondary Outcome Measures:
  • Deepening propofol sedation — as measured by Sedation Agitation Scale, Richmond Agitation Scale Score, and Ramsay sedation scale — lowers esophageal pressure in critical care patients. [ Time Frame: every 10 minutes, while sedated in the ICU ] [ Designated as safety issue: No ]
    The SAS uses a 1 to 7 point scale to make a determination of the patient's level of agitation and sedation from a rating of 7 dangerously agitated to a rating of 1 unarousable (Table 1). Clinical sedation assessments using SAS and RASS scales will be measured every 10 minutes through the study period.

  • Modifying the target level of BIS titration affects upper esophageal pressures and esophageal peristalsis. [ Time Frame: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU ] [ Designated as safety issue: No ]
    Upper esophageal sphincter pressures, transient LES relaxations, and regurgitations will be evaluated by the GI team from recorded data from high resolution manometry.

  • There is an association between ventilator associated pneumonia and baseline lower esophageal and barrier pressure. [ Time Frame: daily, until hospital discharge ] [ Designated as safety issue: No ]
    Patients will be followed for their stay in the hospital for occurrence of ventilator associated pneumonia.


Enrollment: 1
Study Start Date: July 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BIS 70
BIS levels of 70, will be targeted (Anxiolysis/high-frequency EEG activity, beta-augmentation);
Other: BIS 70 maintained
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 70.
Other Names:
  • sedation
  • propofol
  • BIS monitor
  • esophageal pressure
  • esophageal function
Active Comparator: BIS 50
BIS levels of 50 will be targeted, (Low frequency EEG activity, theta-delta activity)
Other: BIS level 50
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 50.
Other Names:
  • sedation
  • propofol
  • BIS monitor
  • esophageal pressure
  • esophageal function
Active Comparator: BIS 35
BIS levels of 35 will be targeted (low frequency EEG activity)
Other: BIS 35
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 35.
Other Names:
  • sedation
  • propofol
  • BIS monitor
  • esophageal pressure
  • esophageal function

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173263

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Alparslan Turan, M.D. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Alparslan Turan, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01173263     History of Changes
Other Study ID Numbers: 10-226
Study First Received: July 21, 2010
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
breathing machine
mechanical ventilator

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 22, 2014