NCT01868178

Brief Summary

The aim of this study was to estimate the relationship between BIS and Spectral Entropy values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2008

Shorter than P25 for all trials

Geographic Reach
1 country

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

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
Last Updated

June 4, 2013

Status Verified

May 1, 2013

Enrollment Period

4 months

First QC Date

November 12, 2012

Last Update Submit

May 30, 2013

Conditions

Intraoperative Awareness

Keywords

awareness

Outcome Measures

Primary Outcomes (1)

  • BIS index

    change from baseline at 15 min

Secondary Outcomes (1)

  • entropy values

    24 h after emergency from anaesthesia

Other Outcomes (1)

  • explicit and implicit memory and dreams recall.

    after 24 h

Study Arms (1)

BIS Spectral Entropy Group

intraoperative monitoring with BIS and Spectral Entropy

Device: BIS and Spectral Entropy

Interventions

BIS and Spectral EntropyDEVICE

The aim of the study was investigated the effectiveness of Spectral Entropy and BIS in avoiding awareness

BIS Spectral Entropy Group

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

female patients, aged 30-60 years , scheduled for minor elective surgery lasts between 1 and 3 hours were enrolled.

You may qualify if:

  • American society of anesthesiologist physical status I-II
  • Italian native speakers

You may not qualify if:

  • Psychiatric or neurologic diseases
  • Acoustic impairment
  • Obesity (Body Mass Index \> 30)
  • Substance dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Catholic University of Sacred Heart

Rome, Rm, 00168, Italy

Location

Catholic University

Rome, Rm, 00168, Italy

Location

Related Publications (10)

  • Domino KB, Posner KL, Caplan RA, Cheney FW. Awareness during anesthesia: a closed claims analysis. Anesthesiology. 1999 Apr;90(4):1053-61. doi: 10.1097/00000542-199904000-00019.

    PMID: 10201677BACKGROUND

  • Heier T, Steen PA. Awareness in anaesthesia: incidence, consequences and prevention. Acta Anaesthesiol Scand. 1996 Oct;40(9):1073-86. doi: 10.1111/j.1399-6576.1996.tb05569.x.

    PMID: 8933848BACKGROUND

  • Liu WH, Thorp TA, Graham SG, Aitkenhead AR. Incidence of awareness with recall during general anaesthesia. Anaesthesia. 1991 Jun;46(6):435-7. doi: 10.1111/j.1365-2044.1991.tb11677.x.

    PMID: 2048657BACKGROUND

  • O'Connor MF, Daves SM, Tung A, Cook RI, Thisted R, Apfelbaum J. BIS monitoring to prevent awareness during general anesthesia. Anesthesiology. 2001 Mar;94(3):520-2. doi: 10.1097/00000542-200103000-00025.

    PMID: 11374615BACKGROUND

  • Brice DD, Hetherington RR, Utting JE. A simple study of awareness and dreaming during anaesthesia. Br J Anaesth. 1970 Jun;42(6):535-42. doi: 10.1093/bja/42.6.535. No abstract available.

    PMID: 5423844BACKGROUND

  • Ranta SO, Laurila R, Saario J, Ali-Melkkila T, Hynynen M. Awareness with recall during general anesthesia: incidence and risk factors. Anesth Analg. 1998 May;86(5):1084-9. doi: 10.1097/00000539-199805000-00035.

    PMID: 9585303BACKGROUND

  • Ghoneim MM. Incidence of and risk factors for awareness during anaesthesia. Best Pract Res Clin Anaesthesiol. 2007 Sep;21(3):327-43. doi: 10.1016/j.bpa.2007.05.002.

    PMID: 17900012BACKGROUND

  • Kissin I. Depth of anesthesia and bispectral index monitoring. Anesth Analg. 2000 May;90(5):1114-7. doi: 10.1097/00000539-200005000-00021. No abstract available.

    PMID: 10781463BACKGROUND

  • Paolo Martorano P, Falzetti G, Pelaia P. Bispectral index and spectral entropy in neuroanesthesia. J Neurosurg Anesthesiol. 2006 Jul;18(3):205-10. doi: 10.1097/01.ana.0000206229.38883.d2.

    PMID: 16799349BACKGROUND

  • Liu J, Singh H, White PF. Electroencephalographic bispectral index correlates with intraoperative recall and depth of propofol-induced sedation. Anesth Analg. 1997 Jan;84(1):185-9. doi: 10.1097/00000539-199701000-00033.

    PMID: 8989022BACKGROUND

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • De Cosmo Germano, PhD

    Catholic University of Sacred Heart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 12, 2012

First Posted

June 4, 2013

Study Start

September 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 4, 2013

Record last verified: 2013-05

Locations

IT(2)