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

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

Interventions

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.

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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio

  lead OTHER

Principal Investigators

• Erik Boatman, M.D. · University of Texas

Study Design

Allocation

RANDOMIZED

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2014-04-30

Completion

2014-08-31

Countries

• United States

Study Locations