Physostigmine After General Anesthesia

Postoperative Nausea and Vomiting Clinical Trial

Official title:

The Use of Physostigmine in Elderly Patients in the Postoperative Recovery-phase After General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00850850
• Other study ID #: 2006-002497-22
• 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

• Anesthesia Recovery Period
• Postoperative Nausea and Vomiting

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