The Use of Physostigmine in Elderly Patients in the Postoperative Recovery-phase After General Anesthesia
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Diabetics
- •Any history of neurological and psychiatric disorder
- •Parkinson's disease
- •Disorders of the gastrointestinal and urogenital tracts
Arms & Interventions
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.
Intervention: physostigmine (Drug)
NaCl
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).
Intervention: Isotonic sodium chloride solution (Drug)
Outcomes
Primary Outcomes
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
Time Frame: 60 minutes
Secondary Outcomes
- 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)