NCT00507195

Brief Summary

The study proposes to analyze the difference in the rapidity of the recovery of post operative cognition immediately after extubation and 20, 40 and 60 minutes post extubation and neuropsychological complications (delirium) after 48 hours following general anesthesia using a prospective, randomized approach. Patients undergoing any type of surgery with the exception of cranial, cardiac or thoracic surgery can be enrolled in the study.

Trial Health

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Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2007

Completed
Last Updated

July 26, 2007

Status Verified

May 1, 2007

First QC Date

July 23, 2007

Last Update Submit

July 24, 2007

Conditions

Anesthesia Recovery PeriodDelirium, Dementia, Cognitive DisordersNeurobehavioural ManifestationMental Competency

Keywords

Postanethesia cognitive recoveryPostoperative deliriumhypnoticspropofolsevofluranedesfluranepostoperative cognitive recovery

Interventions

Hypnotics: propofol, sevoflurane, desflurane,desflurane,midazolamDRUG
Also known as: Propofol,, sevoflurane,, desflurane,, midazolam

Eligibility Criteria

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

You may qualify if:

  • Adult age patients undergoing general anesthesia

You may not qualify if:

  • Cerebral and cardiac surgery
  • Surgical procedures required postoperative delayed extubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Policlinico Umberto I, University of Rome La Sapienza,

Rome, 00161, Italy

RECRUITING

Related Publications (1)

  • Bilotta F, Doronzio A, Stazi E, Titi L, Zeppa IO, Cianchi A, Rosa G, Paoloni FP, Bergese S, Asouhidou I, Ioannou P, Abramowicz AE, Spinelli A, Delphin E, Ayrian E, Zelman V, Lumb P. Early postoperative cognitive dysfunction and postoperative delirium after anaesthesia with various hypnotics: study protocol for a randomised controlled trial--the PINOCCHIO trial. Trials. 2011 Jul 6;12:170. doi: 10.1186/1745-6215-12-170.

    PMID: 21733178DERIVED

MeSH Terms

Conditions

DeliriumDementiaCognitive DysfunctionEmergence Delirium

Interventions

SevofluraneDesfluranePropofolMidazolam

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesCognition DisordersPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl EthersPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Federico Bilotta, MD, PhD

    University of Roma La Sapienza

    STUDY CHAIR

Central Study Contacts

Federico Bilotta, MD, PhD

CONTACT

39 339 33 708 22bilotta@tiscali.it

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2007

First Posted

July 26, 2007

Study Start

May 1, 2007

Last Updated

July 26, 2007

Record last verified: 2007-05

Locations

IT(1)