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Evaluation of Closed-loop TIVA Propofol, Sufentanil and Ketamine Guided by BIS Monitor

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ClinicalTrials.gov Identifier: NCT01942356
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:
The purpose of this study is to compare a closed-loop intravenous anesthetic using Bispectral Index as a feedback loop and a controller based on reinforcement learning to titrate dose and intravenous anesthetic that is manually controlled or a standard volatile anesthetic agent titrated by the anesthesiologist to determine improvement in the following parameters as compared to controls: time to discharge from the Post Anesthesia Care Unit, post-operative nausea and vomiting, pain scores and sedation scores.

Condition or disease Intervention/treatment Phase
Acute Cholecystitis Chronic Cholecystitis Procedure: TIVA - Hypotension Procedure: TIVA - Hypertension Procedure: TIVA - Bradycardia Procedure: TIVA - Tachycardia Procedure: INH - Hypotension Procedure: INH - Hypertension Procedure: INH - Bradycardia Procedure: INH - Tachycardia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Evaluation of Closed-loop Titration of the Intravenous Anesthetic Propofol, Sufentanil and Ketamine Guided by BIS Monitor
Study Start Date : September 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Sufentanil

Arm Intervention/treatment
Experimental: RL-TIVA Group
Propofol, ketamine and sufentanil administration for a TIVA (total intravenous anesthetic) will be administered using a Harvard 33 syringe pump connected via a RS 232 interface to the study computer running the RL (Reinforcement Learning) control software. This software platform will collect real time vitals and BIS valises and steer the target controlled infusion pumps and the closed loop controllers. The anesthesiologist will provide interventions based on protocol for TIVA - Hypotension, TIVA - Hypertension, TIVA - Bradycardia and TIVA - Tachycardia .
Procedure: TIVA - Hypotension

Defined as: MAP < 70% of baseline Change NIBP (noninvasive blood pressure) measuring interval from 3 minutes to 1 minute until resolution of the event.

  1. Give 200 mL Fluid Bolus
  2. If not successful, give ephedrine 5 mg bolus
  3. Repeat from 1.) if even is not resolved after 3.)

Procedure: TIVA - Hypertension

Defined as: SBP > 130% of baseline sustained for 2 readings Change NIBP (noninvasive blood pressure) measuring interval from 3 minutes to 1 minute until resolution of the event.

1.) Labetalol 5 mg IV will be administered


Procedure: TIVA - Bradycardia

Defined as: Heart rate < 45 beats/min

1.) Bolus of 0.2 mg glycopyrrolate


Procedure: TIVA - Tachycardia

Defined as: Heart Rate > 90 beats/min

  1. If associated with normal NIBP (MAP > 60 mmHg and SAP < 140): give fluid bolus of 200 mL, repeat once if required. Look for bleeding and treat if required.
  2. If associated with hypertension (SAB > 140 mmHg): proceed with the management of the hypotention during maintenance protocol.
  3. If associated with hypotension (MAP < 60 mmHg): proceed with the management of the hypotnetion during maintenance protocol.

Active Comparator: Manual TIVA Group
Manually titrated TIVA (total intravenous anesethetic) with proposal, ketamine and sufentanil will be administered using an Alaris infusion pump titrated by the anesthesiologist based on blood pressure and heart-rate as is traditionally done and is standard of care with intravenous anesthetics. The anesthesiologist will provide interventions based on protocol for TIVA - Hypotension, TIVA - Hypertension, TIVA - Bradycardia and TIVA - Tachycardia .
Procedure: TIVA - Hypotension

Defined as: MAP < 70% of baseline Change NIBP (noninvasive blood pressure) measuring interval from 3 minutes to 1 minute until resolution of the event.

  1. Give 200 mL Fluid Bolus
  2. If not successful, give ephedrine 5 mg bolus
  3. Repeat from 1.) if even is not resolved after 3.)

Procedure: TIVA - Hypertension

Defined as: SBP > 130% of baseline sustained for 2 readings Change NIBP (noninvasive blood pressure) measuring interval from 3 minutes to 1 minute until resolution of the event.

1.) Labetalol 5 mg IV will be administered


Procedure: TIVA - Bradycardia

Defined as: Heart rate < 45 beats/min

1.) Bolus of 0.2 mg glycopyrrolate


Procedure: TIVA - Tachycardia

Defined as: Heart Rate > 90 beats/min

  1. If associated with normal NIBP (MAP > 60 mmHg and SAP < 140): give fluid bolus of 200 mL, repeat once if required. Look for bleeding and treat if required.
  2. If associated with hypertension (SAB > 140 mmHg): proceed with the management of the hypotention during maintenance protocol.
  3. If associated with hypotension (MAP < 60 mmHg): proceed with the management of the hypotnetion during maintenance protocol.

Active Comparator: Inhaled Sevofluorane Group
An inhaled anesthetic with Sevofluorane will be titrated between 0.8-1.5 MAC (minimum alveolar concentration) by the anesthesiologist based on heart rate and blood pressure which is standard of care for inhaled anesthetics. The anesthesiologist will provide interventions based on protocol for INH - Hypotension, INH - Hypertension, INH - Bradycardia and INH - Tachycardia .
Procedure: INH - Hypotension

Defined as: MAP < 70 % of baseline Change NIBP measuring interval from 3 minutes to 1 minute until resolution of the event.

  1. give a 200 ml fluid bolus (crystalloid).
  2. If not successful, give ephedrine 5 mg bolus.
  3. If not successful decrease volatile by 0.1 MAC.
  4. Repeat from 1) if event is not resolved after step 3) for maximum of 2 iterations

Procedure: INH - Hypertension

Defined as: SBP > 130% of baseline Change NIBP measuring interval from 3 minutes to 1 minute until resolution of the event.

  1. increase Sevoflurane by 0.1 MAC
  2. If not successful after 3 minutes (SBP >130% of baseline), increase Sevoflurane again by 0.1 MAC. Maximum of 1.2 allowed.
  3. If still not successful (SBP >130% of baseline), Labetolol 5mg IV will be administered.

Procedure: INH - Bradycardia

Defined as: Heart Rate < 45 beats/min

1.) Bolus of 0.2 mg glycopyrrolate


Procedure: INH - Tachycardia

Defined as: Heart rate > 90 beats/min

  1. if associated with normal NIBP (MAP > 70% of baseline and SBP <130% of baseline) : give fluid bolus of 200 ml, repeat once if required. (look for bleeding and treat if required).
  2. If associated with hypertension (SBP >130% of baseline) : proceed with the management of the hypertension during maintenance protocol.
  3. If associated with hypotension (MAP < 70% of baseline) : proceed with the management of the hypotension during maintenance protocol.




Primary Outcome Measures :
  1. Time to discharge from PACU [ Time Frame: < 2 hours post operatively ]

Secondary Outcome Measures :
  1. Post operative Nausea and/or vomiting [ Time Frame: < 2 hours post operatively ]
  2. Visual Analog Scale Pain score [ Time Frame: < 2 hours post operatively ]
  3. ALDRETE Sedation Score [ Time Frame: < 2 hours post operatively ]
  4. Time to extubation [ Time Frame: 1-6 hours after the start of surgery ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-65 years of age
  • Body mass index lower or equal to 40 m2/kg
  • Subjects must be able to comprehend spoken and written English or Spanish

Exclusion Criteria:

  • Any type of psychiatric, neurological, or neuromuscular disorder
  • Thyroid disease
  • Alcohol consumption which exceeds 2 drinks per day and/or drug abuse.
  • Allergy to study medication proposal, soy or egg proteins
  • history of drug abuse
  • chronic or acute use of opioids, or other medications affecting the central nervous system
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942356


Locations
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United States, Texas
University Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Erik Boatman, M.D. University of Texas
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01942356    
Other Study ID Numbers: HSC20130047H
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases