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

NCT01942356 | Completed

• 1 other identifier: HSC20130047H
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholecystitis; Chronic Cholecystitis

Outcome Measures

Primary Outcomes (1)

• Time to discharge from PACU

  < 2 hours post operatively

Secondary Outcomes (4)

• Post operative Nausea and/or vomiting

  < 2 hours post operatively

• Visual Analog Scale Pain score

  < 2 hours post operatively

• ALDRETE Sedation Score

  < 2 hours post operatively

• Time to extubation

  1-6 hours after the start of surgery

Study Arms (3)

RL-TIVA Group

EXPERIMENTAL

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; Procedure: TIVA - Hypertension; Procedure: TIVA - Bradycardia; Procedure: TIVA - Tachycardia

Manual TIVA Group

ACTIVE COMPARATOR

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; Procedure: TIVA - Hypertension; Procedure: TIVA - Bradycardia; Procedure: TIVA - Tachycardia

Inhaled Sevofluorane Group

ACTIVE COMPARATOR

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; Procedure: INH - Hypertension; Procedure: INH - Bradycardia; Procedure: INH - Tachycardia

Interventions

TIVA - Hypotension PROCEDURE

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.)

Manual TIVA Group; RL-TIVA Group

TIVA - Hypertension PROCEDURE

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

Manual TIVA Group; RL-TIVA Group

TIVA - Bradycardia PROCEDURE

Defined as: Heart rate \< 45 beats/min 1.) Bolus of 0.2 mg glycopyrrolate

Manual TIVA Group; RL-TIVA Group

TIVA - Tachycardia PROCEDURE

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.

Manual TIVA Group; RL-TIVA Group

INH - Hypotension PROCEDURE

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

Inhaled Sevofluorane Group

INH - Hypertension PROCEDURE

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.

Inhaled Sevofluorane Group

INH - Bradycardia PROCEDURE

Defined as: Heart Rate \< 45 beats/min 1.) Bolus of 0.2 mg glycopyrrolate

Inhaled Sevofluorane Group

INH - Tachycardia PROCEDURE

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.

Inhaled Sevofluorane Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Erik Boatman, M.D.

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 13, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

US (1)