Rivastigmine Patch Compared to Melatonin Patch in Prevention of Postoperative Delirium
Condition: Delirium
MeSH terms: Delirium; Emergence Delirium
Study type: Interventional
Phase: Phase 1/Phase 2

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
    

Intervention name(s): Rivastigmine Transdermal System [Exelon]; Melatonin
Intervention type(s): Drug; Drug
Intervention description(s): compare the ability of the drug in preventing postoperative delirium; compare the ability of the drug in preventing postoperative delirium
Other intervention name(s): Exelon; melatonin patch
Intervention MeSH terms: Melatonin; Rivastigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention