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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00850850
Other study ID # 2006-002497-22
Secondary ID
Status Recruiting
Phase N/A
First received February 24, 2009
Last updated May 26, 2010
Start date December 2009
Est. completion date May 2011

Study information

Verified date May 2010
Source Bispebjerg Hospital
Contact Frank Pott, MD
Phone +4535313531
Email frank.pott@gmail.com
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Description:

The researchers wish to investigate the use of physostigmine in the elderly patients (age > 60 yrs, ASA I-III) in the postoperative recovery-phase after general anesthesia.

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Denmark Bispebjerg Hospital Copenhagen Copenhagen NV

Sponsors (1)

Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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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