Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01551485
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Duration on the First Night After Surgery	Drug: Zolpidem; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement
• Study Start Date: Feb 1, 2012
• Anticipated Primary Completion Date: Aug 1, 2012
• Anticipated Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zolpidem	Drug: Zolpidem; The effect of Zolpidem 10 mg for the first night after surgery is asssessed using PSG
Placebo Comparator: Placebo	Drug: Placebo; Pacebo tablet, blinded given on the first night after surgery

Outcome Measures

Primary Outcome Measures

1. Change in sleep time on the first postoperative night compared to preoperatively. [first night postoperatively - 24 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Total hip or knee replacement in fast-track setup

• Age 60 years or above

• ASA class 1-3

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gentofte Hospital	Gentofte		Denmark

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

• Principal Investigator: Lene Krenk, MD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lene Krenk, Principal investigator, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT01551485
• Other Study ID Numbers: H-3-2011-022
• First Posted: Mar 12, 2012
• Last Update Posted: Aug 8, 2012
• Last Verified: Aug 1, 2012

• Additional relevant MeSH terms: Dyssomnias; Parasomnias; Zolpidem

Study Results

No Results Posted as of Aug 8, 2012