- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04189666
Rivastigmine Patch Compared to Melatonin Patch in Prevention of Postoperative Delirium
Rivastigmine Patch (Exelon Patch) Compared to Melatonin Patch in Prevention of Postoperative Delirium in Elderly
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 7
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
180 elderly patients American Society of Anaesthesiologists physical status I-III aged 60-85 years old undergoing major orthopaedic surgery will be included in this study The day prior to the operation all patients will be examined by an anaesthesia resident ''who is blinded to the study'' for preoperative cognitive impairment using Confusion Assessment Method. Patients with delirium were excluded from the study The 180 patients will be randomly divided into two groups 90 patients each using a computer-generated program. The patches will be given to the ward nurse who is blinded to the study to be administered to the patient 24 hours preoperative, during the operation and 3 days postoperative 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 On the day of the operation, patients will not receive premedication. In the operating room basic monitoring in the form of NIBP, SBP (systolic blood pressure), DBP (diastolic blood pressure), SPO2 (pulse oxygen saturation), ECG (electrocardiogram), will be attached and recorded every 30 mins. Level of intraoperative sedation will be monitored using Ramsay Sedation Scale.
Patients of both groups will receive Regional anaesthesia in the form of spinal or epidural anaesthesia according to Anaesthesia and surgical team preference and according to each case. Patient will be put in the sitting position, back will be sterilized by povidone- iodine, drapes will cover the back of the patient, L4-L5 or L3-L4 level will be palpated and local anaesthetic in the form of 1 ml of 2% lidocaine will be injected subcutaneous In case of spinal anaesthesia; a spinal needle G25 will be introduced. After appearance of CSF, heavy Marcaine will be injected intrathecally.
In case of epidural anaesthesia; a Tuohy needle will be introduced, on feeling loss of resistance a catheter will be threaded upward, secured in place, a test dose of 3 ml 2% lidocaine will be injected, then 12-18 ml of 0.5% isobaric Marcaine will be injected After completing the surgery patients will be sent to the Surgical ICU for postoperative monitoring. basic monitoring in the form of (NIBP, SPO2, ECG) will be monitored continuously and any abnormality will be recorded and managed according to the ICU protocol. All patients will be examined by the same anaesthesia resident ''who is blinded to the study'' for PD using Confusion Assessment Method (CAM) and level of sedation using RSS on the first, second, third and 7th postoperative day and for those who develop PD a CAM-S score will be done to assess the severity of PD.
And patients with delirium will be followed up and managed properly by a Neurology specialist.
Patients in the two groups will be compared regarding incidence and severity of delirium on postoperative days 1, 2 or 3 and 7 The investigator's primary outcome is to compare between the two groups regarding the incidence of developing PD among the elderly patients The secondary outcome is to compare between both groups regarding the severity of PD and level of sedation
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Abassia
-
Cairo, Abassia, Egypt
- Ain Shams University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group R: patients receive Rivastigmine patch
receive a Rivastigmine patch (4.6 mg) 24 h before the operation to 3 days post-operative
|
compare the ability of the drug in preventing postoperative delirium
Other Names:
|
Active Comparator: Group M: patients receive Melatonin patch
receive Melatonin patch (7 mg) 24 h before the operation to 3 days post-operative
|
compare the ability of the drug in preventing postoperative delirium
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
compare between the two groups regarding the incidence of developing Delirium among the elderly patients
Time Frame: seventh postoperative day
|
incidence of developing postoperative delirium by Confusion Assessment Method which consisting of four features: it indicate delirium if features 1 and 2 are present and either feature 3 or 4 is present.
|
seventh postoperative day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
compare between both groups regarding level of sedation
Time Frame: seventh postoperative day
|
level of sedation by Ramsy Sedation Score which consists of 6 points: score 1; patient is Anxious (not sedated), 6; No response to stimulus (deeply sedated)
|
seventh postoperative day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rania Hussien, MD, lLecturer of Anaesthesia, Ain Shams University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Delirium
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Cholinergic Agents
- Enzyme Inhibitors
- Neuroprotective Agents
- Protective Agents
- Antioxidants
- Cholinesterase Inhibitors
- Melatonin
- Rivastigmine
Other Study ID Numbers
- FMASU R58/ 2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Delirium
-
Efficacy Care R&D LtdHadassah Medical OrganizationUnknownDelirium | Delirium, Cause Unknown | Delirium of Mixed Origin | Delirium Confusional State | Delirium Drug-InducedIsrael
-
Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicRecruitingDelirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional StateNorway
-
Menoufia UniversityCompleted
-
Universidad de SantanderUnknownDelirium of Mixed Origin | Hypoactive Delirium | Hyperactive DeliriumColombia
-
Johns Hopkins UniversityNational Institute on Aging (NIA)Active, not recruitingDelirium | Delirium on Emergence | Hearing Loss | Hearing Loss, High-Frequency | Hearing Loss, Sensorineural | Delirium, Cause Unknown | Hearing Loss, Bilateral | Hearing Disability | Delirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional State | Delirium With... and other conditionsUnited States
-
Chinese PLA General HospitalBeijing Tiantan HospitalRecruiting
-
Charite University, Berlin, GermanyBARMERRecruitingDelirium in Old AgeGermany
-
Mayo ClinicCompletedPost-Operative DeliriumUnited States
-
University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRecruitingPostoperative Delirium (POD)Switzerland
-
Qin ZhangNational Natural Science Foundation of ChinaRecruiting
Clinical Trials on Rivastigmine Transdermal System [Exelon]
-
Inha University HospitalCompletedAlzheimer's DiseaseKorea, Republic of
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)CompletedParkinson Disease | Parkinson Disease DementiaUnited States
-
The Cleveland ClinicTerminatedMild Cognitive Impairment | Mild Cognitive DisorderUnited States
-
University of PennsylvaniaCompletedParkinson's Disease | Mild Cognitive ImpairmentUnited States
-
NovartisCompletedParkinson's Disease DementiaUnited States, Belgium, Italy, United Kingdom, Germany, Australia, Austria, Spain, Canada, France, Netherlands, Turkey, Argentina
-
NovartisCompleted
-
University Hospital, LilleCompletedParkinson's Disease | Apathy | no DementiaFrance
-
University of BristolRoyal United Hospitals Bath NHS Foundation TrustRecruitingParkinson DiseaseUnited Kingdom
-
Novartis PharmaceuticalsCompleted