Postoperative Nausea and Vomiting Clinical Trial
Official title:
The Use of Physostigmine in Elderly Patients in the Postoperative Recovery-phase After General Anesthesia
Recovery after general anaesthesia is often prolonged in the elderly. This group is
particularly exposed to post-operative confusion. This has negative personal consequences as
well as consequences for the postoperative care for these patients.
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | May 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Scheduled for surgical acute or elective operation - General anesthesia. - ASA physical status I-III - Age > 60 years Exclusion Criteria: - Asthma and chronic pulmonary diseases - Glaucoma - Diabetics - Any history of neurological and psychiatric disorder - Parkinson's disease - Disorders of the gastrointestinal and urogenital tracts |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Bispebjerg Hospital | Copenhagen | Copenhagen NV |
Lead Sponsor | Collaborator |
---|---|
Bispebjerg Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The readiness to be released from the PACU (assessed by the normal guidelines) It should be noted that for safety reasons the patients remained in the PACU for at least 60 minutes | 60 minutes | No | |
Secondary | Pain, shivering and nausea will also be registered on the standardized form as well as a multiple of physiological measurements. A follow-up will be performed after 12 hours from release from the PACU | 6 hours | No |
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