Overview
Rivastigmine Patch Compared to Melatonin Patch in Prevention of Postoperative Delirium
Status:
Completed
Completed
Trial end date:
2020-05-01
2020-05-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
180 patients will be randomly divided into two groups 90 patients each using a computer-generated program. Group R: 90 patients will receive a Rivastigmine patch (4.6 mg) 24 h before the operation to 3 days post-operative Group M: 90 patients will receive Melatonin patch (7 mg) 24 h before the operation to 3 days post-operative Patients in the two groups will be compared regarding incidence and severity of delirium on postoperative days 1, 2 or 3 and 7Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Ain Shams UniversityTreatments:
Melatonin
Rivastigmine
Criteria
Inclusion Criteria:- American Society of Anaesthesiologists physical status I-III,
- Aged 60-85 years old,
- Undergoing major orthopaedic surgery
Exclusion Criteria:
- History of CNS disorders, such as brain injury, stroke; mental illness; dementia
- Metabolic disorders and electrolyte disturbances
- Alcohol or drug dependence
- Secondary surgery or severe infectious complications
- Severe sensory impairment causing difficulty in communication (deafness or blindness)
- Medications affecting CNS as (Antipsychotics, Anticonvulsants, Antiparkinsonian,
Antidepressants)