NCT01467167

Brief Summary

Recently, a new software program for anesthesia has been developed, called Smart Pilot View. This program monitors the patient, the anesthetic drugs given, and the calculated depth of the anesthesia. The purpose of this study is to determine whether the use of this program improves the quality of anesthesia.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

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

September 14, 2011

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

6 years

First QC Date

September 14, 2011

Last Update Submit

April 15, 2024

Conditions

Anesthesia,General

Keywords

AnesthesiaSmart Pilot ViewPain controlRecovery

Outcome Measures

Primary Outcomes (1)

  • Anesthesia Quality Score

    Anesthesia Quality Score (AQS) is defined as the percentage of time the BIS is within the range of 40-60 AND the mean arterial pressure is within the range of 60-80 mmHg.

    up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)

Secondary Outcomes (7)

  • Total anesthetic drug doses

    up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)

  • Mean intra-operative Noxious Stimulation Response Index (NSRI)

    1 day During surgery (until skin closure)

  • Number of doses of vasoactive substances

    up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)

  • Number of events with motor and vegetative (tearing, sweating) responses

    up to 1 week From start of induction until discharge from post-anesthesia care unit

  • Recovery times (skin closure to extubation; skin closure to orientation)

    up to 1 week From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)

  • +2 more secondary outcomes

Study Arms (2)

Baseline

Baseline group in which patients are anesthetized without the use of Smart Pilot View, according to common practice.

Smart Pilot View Group

Study group in which patients are anesthetized with the use of Smart Pilot View.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgery under general anesthesia scheduled for neurosurgery, gynecology and ear nose and throat surgery.

You may qualify if:

  • Elective surgery
  • General anesthesia
  • American Society of Anesthesiologists Physical Status: I - III
  • Age 18 to 90 years

You may not qualify if:

  • Combined regional and general anesthesia
  • Expected surgery duration \< 30 minutes
  • Central nervous system (CNS) diseases (dementia, cerebrovascular accident, seizures, psychiatric diseases)
  • Regular intake of CNS active drugs (benzodiazepines, antidepressants, antipsychotics, anticonvulsants)
  • Heart surgery on cardio-pulmonary bypass
  • Relevant hepatic disease (Child B or higher)
  • BMI \>35
  • Overt signs of alcohol abuse
  • Contraindications or allergies to drugs used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Medical Center Groningen (UMCG)

Groningen, Netherlands

Location

University Hospital of Bern

Bern, Switzerland

Location

Related Publications (1)

  • Kuizenga MH, Vereecke HEM, Absalom AR, Bucher CH, Hannivoort LN, van den Berg JP, Schmalz L, Struys MMRF, Luginbuhl M. Utility of the SmartPilot(R) View advisory screen to improve anaesthetic drug titration and postoperative outcomes in clinical practice: a two-centre prospective observational trial. Br J Anaesth. 2022 Jun;128(6):959-970. doi: 10.1016/j.bja.2022.02.033. Epub 2022 Mar 28.

    PMID: 35361490DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2011

First Posted

November 8, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations

NL(1)CH(1)