Modulating Surgery-Induced Blood-Brain Barrier Disruption in Elderly: Impact of Dexmedetomidine and Lidocaine, a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Postoperative delirium (POD) is the most common complications (\ 50-60%) in elderly and major challenges to our rapidly growing aging population. Growing evidence suggests a possible role for neuroinflammation in the development of delirium, which is facilitated by a transient increase in blood-brain barrier (BBB) permeability. Lidocaine and dexmedetomidine, commonly used anesthetic adjuncts, have anti-inflammatory properties. Both drugs are reported to have modulatory effect on the intergrity of BBB and associated with a beneficial effect on postoperative neurocognitive dysfunction. In this regard, The investigators aimed to prospectively compare the modulatory effect of the intraoperative administration of dexmedetomidine or lidocaine with a sham control group (normal saline solution) on surgery-induced BBB disruption.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• American Society of Anesthesiologists (ASA) physical status classification I-III

• Undergoing elective open pancreatoduodenectomy

• Voluntary participation in the trial and signed informed consent

Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
jeayoun kim
kimjy0705@naver.com
+821039268786
Time Frame
Start Date: 2023-10-25
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 108
Treatments
Experimental: Dexmedetomidine group
Patients in the dexmedetomidine group will be administered a bolus of 0.3 ug/kg intravenous dexmedetomidine over 10 min before anesthetic induction. After bolus injection, a continuous infusion of 0.3 ug/kg/hr of intravenous dexmedetomidine will be administered until the end of surgery.
Experimental: Lidocaine group
Patients in the lidocaine group will receive a bolus of 1.5 mg/kg intravenous lidocaine over 10 min before induction of anesthesia. A continuous infusion of 1.5 mg/kg/hour of systemic lidocaine will be administered until the end of the surgery.
Placebo_comparator: Control group
Patients in the control group will be administered equal volumes of 0.9% saline using the identical application scheme.
Related Therapeutic Areas
Sponsors
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov