Rivastigmine Patch Compared to Melatonin Patch in Prevention of Postoperative Delirium

NCT04189666 | Completed Phase 1

• 1 other identifier: FMASU R58/ 2019
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 7

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• 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.

  seventh postoperative day

Secondary Outcomes (1)

• compare between both groups regarding level of sedation

  seventh postoperative day

Study Arms (2)

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

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

Drug: Melatonin

Interventions

Rivastigmine Transdermal System [Exelon] DRUG

compare the ability of the drug in preventing postoperative delirium

Also known as: Exelon

Group R: patients receive Rivastigmine patch

Melatonin DRUG

compare the ability of the drug in preventing postoperative delirium

Also known as: melatonin patch

Group M: patients receive Melatonin patch

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anaesthesiologists physical status I-III,
• Aged 60-85 years old,
• Undergoing major orthopaedic surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abassia, Egypt

Location

MeSH Terms

Conditions

Delirium

Interventions

Rivastigmine; Melatonin

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Rania Hussien, MD

  lLecturer of Anaesthesia, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anaesthesia and intensive care

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: December 6, 2019
• Study Start: November 18, 2019
• Primary Completion: April 10, 2020
• Study Completion: May 1, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)