Postoperative Nausea and Vomiting, Anesthesia Recovery Period
Conditions
Keywords
PACU, Physostigmine, Recovery, Postanesthesia Nursing, Wakefulness, General anesthesia, General Anesthetics, Postoperative Period
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.
Interventions
DRUGphysostigmine
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.
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.
Sponsors
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Denmark
Contacts
Primary ContactFrank Pott, MD
Backup ContactCarsten M Pedersen, MSN
Outcome results
None listed