NCT01800578

Brief Summary

the aim of this study was to estimate the relations between Bispectral Index values and explicit or implicit memory or dreams during two different minimal alveolar concentration (MAC) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like epidural analgesia, the requirement of halogenated volatile anesthetics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2005

Typical duration for all trials

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

Study Start

First participant enrolled

September 1, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
Last Updated

February 27, 2013

Status Verified

February 1, 2013

Enrollment Period

3.4 years

First QC Date

November 12, 2012

Last Update Submit

February 25, 2013

Conditions

Consciousness, Level DepressedIntraoperative Awareness

Keywords

Cerebral State Index Monitor

Outcome Measures

Primary Outcomes (1)

  • correlation between BIS and free association test score

    every 15 min during anaesthesia and 24 h after emergency from anaesthesia

Secondary Outcomes (1)

  • MAC of sevoflurane necessary to avoid awareness

    24 h after emergency from anaesthesia

Study Arms (1)

Bispectral Index Group

Device: monitor for depth of hypnosis

Interventions

monitor for depth of hypnosisDEVICE

evaluation of depth of hypnosis \--------------------------------------------------------------------------------

Bispectral Index Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing elective major abdominal surgery

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Sacred Heart

Rome, Rm, 00168, Italy

Location

Related Publications (8)

  • Wong CS. What's the matter of depth of anesthesia? Acta Anaesthesiol Sin. 2001 Mar;39(1):1-2. No abstract available.

    PMID: 11407288BACKGROUND

  • Sandin RH, Enlund G, Samuelsson P, Lennmarken C. Awareness during anaesthesia: a prospective case study. Lancet. 2000 Feb 26;355(9205):707-11. doi: 10.1016/S0140-6736(99)11010-9.

    PMID: 10703802BACKGROUND

  • Schwender D, Klasing S, Daunderer M, Madler C, Poppel E, Peter K. [Awareness during general anesthesia. Definition, incidence, clinical relevance, causes, avoidance and medicolegal aspects]. Anaesthesist. 1995 Nov;44(11):743-54. doi: 10.1007/s001010050209. German.

    PMID: 8678265BACKGROUND

  • Osterman JE, Hopper J, Heran WJ, Keane TM, van der Kolk BA. Awareness under anesthesia and the development of posttraumatic stress disorder. Gen Hosp Psychiatry. 2001 Jul-Aug;23(4):198-204. doi: 10.1016/s0163-8343(01)00142-6.

    PMID: 11543846BACKGROUND

  • Baars BJ. The brain basis of a "consciousness monitor": scientific and medical significance. Conscious Cogn. 2001 Jun;10(2):159-64; discussion 246-58. doi: 10.1006/ccog.2001.0510.

    PMID: 11414712BACKGROUND

  • 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

  • Ekman A, Lindholm ML, Lennmarken C, Sandin R. Reduction in the incidence of awareness using BIS monitoring. Acta Anaesthesiol Scand. 2004 Jan;48(1):20-6. doi: 10.1111/j.1399-6576.2004.00260.x.

    PMID: 14674969BACKGROUND

  • Aceto P, Valente A, Gorgoglione M, Adducci E, De Cosmo G. Relationship between awareness and middle latency auditory evoked responses during surgical anaesthesia. Br J Anaesth. 2003 May;90(5):630-5. doi: 10.1093/bja/aeg113.

    PMID: 12697591BACKGROUND

MeSH Terms

Conditions

Consciousness DisordersIntraoperative Awareness

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersIntraoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • De Cosmo Germano, PhD

    Catholic University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 12, 2012

First Posted

February 27, 2013

Study Start

September 1, 2005

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 27, 2013

Record last verified: 2013-02

Locations

IT(1)