DeliriumPhase 1/2NCT04189666
Rivastigmine Patch Compared to Melatonin Patch in Prevention of Postoperative Delirium
A Phase 1/2 study testing Rivastigmine Transdermal System [Exelon] and Melatonin in people with Delirium, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- Rivastigmine Transdermal System [Exelon] and Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Nov 2019to 1 May 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesiologists physical status I-III,
- Aged 60-85 years old,
- Undergoing major orthopaedic surgery
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivastigmine Transdermal System [Exelon]Drug
Also called Exelon
compare the ability of the drug in preventing postoperative delirium
MelatoninDrug
Also called melatonin patch
compare the ability of the drug in preventing postoperative delirium
| Study group | Role | What they receive |
|---|---|---|
| Group R: patients receive Rivastigmine patch | Active comparator | receive a Rivastigmine patch (4.6 mg) 24 h before the operation to 3 days post-operative Receives: Drug: Rivastigmine Transdermal System [Exelon] |
| Group M: patients receive Melatonin patch | Active comparator | receive Melatonin patch (7 mg) 24 h before the operation to 3 days post-operative Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare between the two groups regarding the incidence of developing Delirium among the elderly patients
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.
Measured: seventh postoperative day
Secondary outcomes (1)
compare between both groups regarding level of sedation
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)
Measured: seventh postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start18 Nov 2019
- Primary completion10 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Maher Hussien, Ain Shams University
- Investigators
- Rania Hussien, MD, Principal investigator, lLecturer of Anaesthesia, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189666
- Sponsor's protocol ID
- FMASU R58/ 2019
- Status last verified
- Jul 2020
- First submitted
- 24 Nov 2019
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivastigmine Patch (Exelon Patch) Compared to Melatonin Patch in Prevention of Postoperative Delirium in Elderly
- ClinicalTrials.gov ID
- NCT04189666
- Acronym / sponsor ID
- FMASU R58/ 2019
- Conditions
- Delirium
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group R: patients receive Rivastigmine patch | Active comparator | Drug: Rivastigmine Transdermal System [Exelon]receive a Rivastigmine patch (4.6 mg) 24 h before the operation to 3 days post-operative |
| Group M: patients receive Melatonin patch | Active comparator | Drug: Melatoninreceive Melatonin patch (7 mg) 24 h before the operation to 3 days post-operative |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anaesthesiologists physical status I-III,
- Aged 60-85 years old,
- Undergoing major orthopaedic surgery
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivastigmine Transdermal System [Exelon]Also: Exeloncompare the ability of the drug in preventing postoperative delirium | Drug | Group R: patients receive Rivastigmine patch |
| MelatoninAlso: melatonin patchcompare the ability of the drug in preventing postoperative delirium | Drug | Group M: patients receive Melatonin patch |
Primary outcome
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.
1 secondary outcome
compare between both groups regarding level of sedation
Time frame: seventh postoperative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania Hussien, MD principal investigator
lLecturer of Anaesthesia, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rivastigmine Transdermal System [Exelon] and Melatonin in people with Delirium, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare between the two groups regarding the incidence of developing Delirium among the elderly patients (time frame: seventh postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.