Physostigmine After General Anesthesia

Bispebjerg Hospital

Status: Unknown

Conditions: Postoperative Nausea and Vomiting; Anesthesia Recovery Period

Treatments: Drug: Isotonic sodium chloride solution; Drug: physostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT00850850

2006-002497-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Physostigmine

Active Comparator group

Description:

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.

Treatment:

Drug: physostigmine

NaCl

Placebo Comparator group

Description:

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).

Treatment:

Drug: Isotonic sodium chloride solution