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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physostigmine | Active Comparator | 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. |
|
| NaCl | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physostigmine | Drug | 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank Pott, MD | Contact | +4535313531 | 4358 | frank.pott@gmail.com |
| Carsten M Pedersen, MSN | Contact | +4535313983 | 4845 | carstenmp@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Frank Pott, MD | Bispebjerg Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Recruiting | Copenhagen | Copenhagen NV | 2400 | Denmark |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D010830 | Physostigmine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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|
| Isotonic sodium chloride solution | Drug | 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. |
|
|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D009930 |
| Organic Chemicals |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |