NCT03807271

Brief Summary

There are studies that suggest that unsatisfying levels of anesthesia can cause peri- and postoperative complications in the patient undergoing surgery. Having a unnecessary "deep" anesthesia level can be harmful, causing acute renal failure, injure to myocard, cause delirium and increase the mortality rate. Being too "light", on the other hand, can make the patient experience awareness when muscle relaxant is used. This can lead to serious psychological struggles. Evaluating the depth of anesthesia is the most important task of the anesthesia team, but can be difficult because clinical signs depend on many factors. In addition to clinical evaluation, EEG is commonly used for interpreting the level of anesthesia in todays practice. Unfortunately, this method is not always accurate and has a delay. New devices are now developed to calculate the anesthesia level based on the drugs given. The level is simultaneously presented graphically on screen. The purpose of this study is to investigate and compare clinical parameters within patients undergoing general anesthesia, with and without the use of such devices. Hemodynamic stability, less use of adrenergics, higher EEG-levels, a more rapid wake-up and shorter time in post operative care can indicate a more precise level of anesthesia, hence, promote patient safety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

January 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2019

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

January 9, 2019

Last Update Submit

December 10, 2019

Conditions

Anesthesia, General

Keywords

Anesthesia, MethodsAnesthesia, AnalysisPatient SafetyAnesthetics/administration and dosage

Outcome Measures

Primary Outcomes (1)

  • Mean Arterial Pressure (MAP)

    Maximum 5 hours

Secondary Outcomes (12)

  • Heart Rate (HR)

    Maximum 5 hours

  • Bispectral Index (BIS)

    Maximum 5 hours

  • Total dosis of Propofol in milligrams

    Maximum 5 hours

  • Total dosis of Remifentanil in micrograms

    Maximum 5 hours

  • Total dosis of Ephedrine in milligrams

    Maximum 5 hours

  • +7 more secondary outcomes

Study Arms (2)

Smart Pilot(R) View

EXPERIMENTAL

Anesthesia provided by standard procedure, additionally guided by Smart Pilot(R) View, a device with calculated and graphically produced depth of anesthesia.

Device: Calculated and graphically produced depth of anesthesia (Smart Pilot® View)

Standard

NO INTERVENTION

Anesthesia provided by standard procedure.

Interventions

Calculated and graphically produced depth of anesthesia (Smart Pilot® View)DEVICE

Smart Pilot® View is a device integrated in the ventilator used under general anesthesia. The depth of anesthesia is calculated based on age, weight, height and the medication given - both volatiles and intravenous. The device does not control the supply of medication directly, but provides an estimate of anesthesia depth that can help the anesthesia team to control the supply of anesthetic agents under general anesthesia, ie indirectly.

Smart Pilot(R) View

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-3
  • Standard premedication
  • General anesthesia, total intravenous anesthesia

You may not qualify if:

  • Alcoholics
  • BMI 35 or higher
  • Unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anestesiavdeling Lillehammer Sykehus

Lillehammer, Oppland, 2609, Norway

Location

Related Publications (1)

  • Strand H, Elshaug AC, Bernersen O, Ballangrud R. Effectiveness of the advisory display SmartPilot(R) view in the assessment of anesthetic depth in low risk gynecological surgery patients: a randomized controlled trial. BMC Anesthesiol. 2022 Feb 28;22(1):57. doi: 10.1186/s12871-022-01593-w.

    PMID: 35227197DERIVED

Study Officials

  • Heidi Vifladt, MD

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The anesthesia team must know if the anesthesia will be given by standard procedure or guided by the calculating device in addition.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 16, 2019

Study Start

January 14, 2019

Primary Completion

November 13, 2019

Study Completion

November 13, 2019

Last Updated

December 11, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)