Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2009-12-31
2011-05-31
Brief Summary
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The hypothesis is that physostigmine will decrease the amount of time in the post-anaesthesia care unit (PACU ), the postoperative amount of pain and shivering and finally post-operative confusion.
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Detailed Description
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Apart from the beneficial effects for the patient, the lessened amount of time in the PACU will release caregiving resources and thereby increase the efficacy of the PACU.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Physostigmine
Patients who have difficulties in awakening from the general anaesthesia and do not suffer from excess nausea or vomiting will be randomised to receive 1 mg of physostigmine.
physostigmine
1 mg of physostigmine time 0 min. If the condition persisted after 15 min. the same amount of active drug would be administered once again.
NaCl
Patients who have difficulties in awakening from the general anaesthesia and do not suffer from excess nausea or vomiting will be randomised to receive 1 ml of isotonic sodium chloride solution (placebo).
Isotonic sodium chloride solution
Patients who have difficulties in awakening from the general anaesthesia and do not suffer from excess nausea or vomiting will be randomised to receive 1 ml of isotonic sodium chloride solution (placebo) time 0 min. If the condition persisted after 15 min. the same amount of non-active drug would be administered once again.
Interventions
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physostigmine
1 mg of physostigmine time 0 min. If the condition persisted after 15 min. the same amount of active drug would be administered once again.
Isotonic sodium chloride solution
Patients who have difficulties in awakening from the general anaesthesia and do not suffer from excess nausea or vomiting will be randomised to receive 1 ml of isotonic sodium chloride solution (placebo) time 0 min. If the condition persisted after 15 min. the same amount of non-active drug would be administered once again.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* General anesthesia.
* ASA physical status I-III
* Age \> 60 years
Exclusion Criteria
* Glaucoma
* Diabetics
* Any history of neurological and psychiatric disorder
* Parkinson's disease
* Disorders of the gastrointestinal and urogenital tracts
60 Years
ALL
No
Sponsors
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Bispebjerg Hospital
OTHER
Responsible Party
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ICU
Principal Investigators
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Frank Pott, MD
Role: STUDY_DIRECTOR
Bispebjerg Hospital
Locations
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Bispebjerg Hospital
Copenhagen, Copenhagen NV, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2006-002497-22
Identifier Type: -
Identifier Source: org_study_id
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