Rivastigmine Patch Compared to Melatonin Patch in Prevention of Postoperative Delirium

July 8, 2020 updated by: Rania Maher Hussien, Ain Shams University

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

Completed

Conditions

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

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Abassia
      • Cairo, Abassia, Egypt
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Exelon
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:
  • melatonin patch

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rania Hussien, MD, lLecturer of Anaesthesia, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2019

Primary Completion (Actual)

April 10, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

November 24, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (Actual)

December 6, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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

Clinical Trials on Rivastigmine Transdermal System [Exelon]

3
Subscribe