Physostigmine After General Anesthesia

Not Applicable

• Conditions: Postoperative Nausea and Vomiting; Anesthesia Recovery Period
• Interventions: Drug: Isotonic sodium chloride solution; Drug: physostigmine

• Registration Number: NCT00850850
• Lead Sponsor: Bispebjerg Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Study Start: 2009-12
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-26
• Last Update Posted: 2010-05-27
• Primary Completion: 2011-03
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl	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).
Physostigmine	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.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Copenhagen NV, Denmark