Neurocognitive Function of Elderly Patients
Conditions
Keywords
neurocognitive function, POCD, Dexmedetomidine, lidocaine
Brief summary
dexmedetomidine infusion or lidocaine infusion starting before induction of intravenous general anesthesia and continue as infusion intraoperative can reduce postoperative cognitive dysfunction incidence (primary outcome), postoperative cognitive dilirium, postoperative pain, opioid consumption, postoperative inflammatory response and postoperative adverse events (secondary outcomes) in elderly patients undergoing ERCP.
Detailed description
Randomization will be achieved using a computer-generated random sequence, and group allocation will be concealed using opaque, sealed envelopes. Both patients and study staff, including those administering the interventions and assessing outcomes will be blinded to the group assignments. The tested syringes will be prepared by the responsible nurse in equal volumes of 50 ml. All data of the patients will be confidential with secret codes and private file for each patient, all given data will be used for the current medical research only. The prefilled 50 mL syringes will contain either dexmedetomidine 4 µg/mL or lidocaine 10 mg/mL or NaCl 0.9%. Ten minutes before anesthesia induction all patients will receive an IV infusion at a rate of 0.9mL/kg/h for 10 minutes. This rate corresponds to 0.6 µg/kg dexmedetomidine or 1.5 mg/kg lidocaine. Afterwards, all patients will receive an infusion at a rate of 0.15mL/kg/h until the end of procedure; this rate corresponds to 1.5 mg/kg/h of lidocaine or 0.6 µg/kg/h of dexmedetomidine.
Interventions
DRUGDexmedetomidine
patients will receive 0.6 µg/kg dexmedetomidine bolus 10 min before induction then it will be infused intravenously at a rate of 0.6 μg/Kg/h. until end of surgery.
DRUGlidocaine
patients will be received 1.5 mg/kg lidocaine bolus 10min before induction of anaesthesia, followed by continuous infusion at a rate of 1.5 mg/Kg/h until end of surgery.
DRUGnormal saline
patients will receive 0.9% isotonic saline bolus followed by IV infusion at a rate of 0.9 ml/Kg/h till the end of surgery.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Randomization will be achieved using a computer-generated random sequence, and group allocation will be concealed using opaque, sealed envelopes. Both patients and study staff, including those administering the interventions and assessing outcomes will be blinded to the group assignments. The tested syringes will be prepared by the responsible nurse in equal volumes of 50 ml. All data of the patients will be confidential with secret codes and private file for each patient, all given data will be used for the current medical research only.
Intervention model description
patiants will randomly assigned into 3 groups : lidocaine group , dexmedetomidene group , control group ( receive normal saline).
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The study will include all patients aged 65 years or older of both sex with an ASA I -II - III (as controlled HTN, controlled DM), (MMSE\>24) who scheduled for elective ERCP under total intravenous general anesthesia.
Exclusion criteria
:will involve patients lacking informed consents, with severe cardiovascular, respiratory, central nervous system, or kidney dysfunction, communication or assessment impairments, and suspected severe neurocognitive impairment (MMSE score \<24). patients with anticipated airway difficulties, alcohol or drug dependence, current sedative, antidepressant, or corticosteroid use, allergy to dexmedetomidine, lidocaine or other used anesthetics, baseline heart rate less than 50 beats per minute due to bradycardia, sick sinus syndrome, or second-degree or higher atrioventricular block without a pacemaker. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of POCD | 24-72 hours postoperatively | determined by The mini-mental state examination( range from 0 to 30 , scores \> 25 interpreted as normal cognitive status) score mini-cog score Richmond Agitation Sedation Scale(range from +4 to -5 , score 0 signifies a calm and alert patient ) . |
| the incidence of post operative cognitive dysfunction | change from baseline at 12 weeks | determined by The mini-mental state examination score at post operative day 1 ,post operative day 3 scores \>25 interpreted as normal cognitive status. |
Countries
Egypt
Outcome results
None listed