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Clinical Trials/EUCTR2004-003796-37-DK
EUCTR2004-003796-37-DK
Active, not recruiting
Not Applicable

Effekt af melatonin på forekomsten af postoperativ træthed og søvnforstyrrelser efter laparoskopisk kolecystektomi. En randomiseret dobbelt-blindet placebo kontrolleret undersøgelse. - MEL-MIS

Dept. of surg.gastroent., Gentofte University Hospital, Copenhagen0 sites100 target enrollmentDecember 8, 2004
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Conditionspostoperativ fatigue og søvnforstyrrelser

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
postoperativ fatigue og søvnforstyrrelser
Sponsor
Dept. of surg.gastroent., Gentofte University Hospital, Copenhagen
Enrollment
100
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 8, 2004
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dept. of surg.gastroent., Gentofte University Hospital, Copenhagen

Eligibility Criteria

Inclusion Criteria

  • •1\.Vanlig indikation for laparoskopisk kolecystektomi.
  • •2\.Alder mellem 18 og 80 år.
  • •3\.ASA klasse I\-III.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\.Præoperativ vedvarende behandling (i en uge før operationen) med psykofarmaka af enhver art, opioider og anxiolytica (inklusiv sovepiller af enhver art).
  • •2\.Dagligt alkoholforbrug ?5 genstande.
  • •3\.Præoperativ betablokker behandling.
  • •4\.AK\-behandling med marevan eller marcoumar.
  • •5\.Kendt søvnlidelse.
  • •6\.Forudsigelig dårlig kompliance (sprogvanskeligheder, psyk. tilstande m.v.).
  • •7\. Gravide og ammende.
  • •8\.Manglende skriftlig samtykke.
  • •9\. Endokrin sygdom i medicinsk behandling

Outcomes

Primary Outcomes

Not specified

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