Physostigmine After General Anesthesia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Nausea and Vomiting, Anesthesia Recovery Period

Intervention / Treatment
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* Drug: physostigmine
* Drug: Isotonic sodium chloride solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physostigmine<br>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. | Drug: physostigmine<br>* 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.<br>* Other names: Fysostigmin; Methylcarbamate; Erserine; Eserolein;|
| Placebo Comparator: NaCl<br>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). | Drug: Isotonic sodium chloride solution<br>* 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.<br>* Other names: NaCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PACU, Physostigmine, Recovery, Postanesthesia Nursing, Wakefulness, General anesthesia, General Anesthetics, Postoperative Period