NCT00113906

Brief Summary

Circadian disturbances occur after surgery. A double blinded, placebo controlled randomized clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep disturbances and general wellbeing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2

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

March 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

February 11, 2014

Status Verified

June 1, 2005

Enrollment Period

1.4 years

First QC Date

June 10, 2005

Last Update Submit

February 10, 2014

Conditions

Postoperative ComplicationsFatigueDyssomnias

Keywords

melatonin,fatigue,sleep quality,circadian,postoperativePostoperative fatiguepostoperative sleep disturbancegeneral wellbeing

Outcome Measures

Primary Outcomes (1)

  • Fatigue

Secondary Outcomes (3)

  • Sleep quality

  • general wellbeing

  • pain

Interventions

melatoninDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Operation for gall bladder disease
  • Age over 18 years

You may not qualify if:

  • Known preoperative sleep disturbance
  • Anticoagulant therapy
  • Psychiatric disease
  • Lack of written informed consent
  • Treatment with hypnotics within one week prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Glostrup

Glostrup Municipality, Copenhagen, 2900, Denmark

Location

Copenhagen University Hospital, Gentofte

Hellerup, Copenhagen, 2900, Denmark

Location

MeSH Terms

Conditions

Postoperative ComplicationsFatigueDyssomniasSleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsSleep Wake DisordersNervous System DiseasesMental DisordersSleep Disorders, Intrinsic

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Ismail Gögenur, MD

    University Hospital, Gentofte, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2005

First Posted

June 13, 2005

Study Start

March 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

February 11, 2014

Record last verified: 2005-06

Locations

DK(2)