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

NACompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

August 31, 2014

Conditions
Acute CholecystitisChronic 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."

Trial Locations (1)

78229

University Hospital, San Antonio

All Listed Sponsors
lead

The University of Texas Health Science Center at San Antonio

OTHER

NCT01942356 - Evaluation of Closed-loop TIVA Propofol, Sufentanil and Ketamine Guided by BIS Monitor | Biotech Hunter | Biotech Hunter