Rivastigmine Patch Compared to Melatonin Patch in Prevention of Postoperative Delirium

NCT ID: NCT04189666

Last Updated: 2020-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-18
• Study Completion Date: 2020-05-01

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

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

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group R: patients receive Rivastigmine patch

receive a Rivastigmine patch (4.6 mg) 24 h before the operation to 3 days post-operative

Group Type: ACTIVE_COMPARATOR

Rivastigmine Transdermal System [Exelon]

Intervention Type: DRUG

compare the ability of the drug in preventing postoperative delirium

Group M: patients receive Melatonin patch

receive Melatonin patch (7 mg) 24 h before the operation to 3 days post-operative

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DRUG

compare the ability of the drug in preventing postoperative delirium

Interventions

Rivastigmine Transdermal System [Exelon]

compare the ability of the drug in preventing postoperative delirium

Intervention Type: DRUG

Melatonin

compare the ability of the drug in preventing postoperative delirium

Intervention Type: DRUG

Other Intervention Names

Exelon; melatonin patch

Eligibility 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)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Rania Maher Hussien

Lecturer of Anaesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rania Hussien, MD

Role: PRINCIPAL_INVESTIGATOR

lLecturer of Anaesthesia, Ain Shams University

Locations

Ain Shams University

Cairo, Abassia, Egypt

Countries

Egypt

Other Identifiers

FMASU R58/ 2019

Identifier Type: -

Identifier Source: org_study_id