NCT01551485

Brief Summary

Sleep after surgery has been found to be very distrubed immediately after major surgery. This is also seen after fast-track hip and knee replacement with length of stay of less than 3 days. Disturbed sleep has many adverse effects i.e. fatigue, possible hyperalgesia and decline in cognitive abilities.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

February 6, 2012

Last Update Submit

August 7, 2012

Conditions

Sleep Duration on the First Night After Surgery

Outcome Measures

Primary Outcomes (1)

  • Change in sleep time on the first postoperative night compared to preoperatively.

    The primary endpoint is an evaluation of sleep stages on the first night postoperatively compared to preoperative measures for the same individual

    first night postoperatively - 24 hours

Study Arms (2)

Zolpidem

EXPERIMENTAL
Drug: Zolpidem

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ZolpidemDRUG

The effect of Zolpidem 10 mg for the first night after surgery is asssessed using PSG

Zolpidem
PlaceboDRUG

Pacebo tablet, blinded given on the first night after surgery

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Total hip or knee replacement in fast-track setup
  • Age 60 years or above
  • ASA class 1-3

You may not qualify if:

  • Anesthesia within the pas 30 days
  • Daily use of alcohol \> 21 units / week
  • Use of anxiolytics or hypnotics within the past 30 days
  • Inability to read and understand Danish
  • Marked reduction of sight or hearing
  • Parkinson's disease or other neurological disaese causing function deficits
  • Inability to cooperate to sleep monitoring
  • allergy to the drug tested

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte Hospital

Gentofte Municipality, Denmark

Location

Related Publications (1)

  • Krenk L, Jennum P, Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement. J Clin Sleep Med. 2014 Mar 15;10(3):321-6. doi: 10.5664/jcsm.3540.

    PMID: 24634631DERIVED

MeSH Terms

Interventions

Zolpidem

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Lene Krenk, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 6, 2012

First Posted

March 12, 2012

Study Start

February 1, 2012

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

DK(1)