Intravenous dexmedetomidine
DrugIntravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)
Other names: Intravenous Precedex
NCT Number: NCT06192615
This is a pragmatic phase III, randomized, blinded, double placebo-controlled, three-arm trial of elderly patients following cardiac surgery to assess the relationship between nighttime intravenous (IV) and sublingual dexmedetomidine on postoperative delirium and functional outcomes after surgery.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Phase 3
Cedars-Sinai Medical Center, Los Angeles, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)
Other names: Intravenous Precedex
Sublingual dexmedetomidine (120 μg)
Other names: Sublingual Precedex
Intravenous placebo of 0.9% saline administered over 40 minutes
Other names: Placebo
Inert sublingual film
Other names: Placebo
Time frame: Postoperative day 1
The primary outcome will be delirium occurring on postoperative day one. Delirium will be assessed using the Confusion Assessment Method (CAM) twice daily. Delirium will be defined as present if either the morning or afternoon assessment are positive for delirium.
Time frame: Postoperative Day 1 to Day 7
Postoperative delirium will also be assessed as a secondary outcome assessed within the first three days after surgery, and separately within the first seven days following surgery. Delirium will be assessed using the CAM in the same fashion as the primary outcome. In the event the patient is reintubated the CAM-ICU may also be used to assess for postoperative delirium as a secondary outcome.
Time frame: Postoperative day 1 to day 7
Delirium severity will be assessed using the CAM-Severity (CAM-S) within the first three days following surgery, and separately within the first seven days following surgery. The CAM-S ranges from 0 (no delirium features) to 19, with higher scores indicating worsening delirium severity.
Time frame: 30, 180 and 365 days
Global cognitive function will be assessed with the T-MoCA in-hospital and at three time points after hospital discharge. Different versions of the T-MOCA will be administered at each time point to minimize learning effects. The T-MoCA ranges from 0 (worst) to 22 (best) points, does not require visual cues or writing, and importantly, can be administered over the phone.
Time frame: 30, 180 and 365 days
Global health will be assessed at 30, 180 and 365 days using the Patient Reported Outcome Measurement Information System (PROMIS) 29 Profile version 2.1. This assessment results in several subscale scores, each reported as a t-score.
Time frame: Postoperative day 1 to day 7
Pain will be assessed within the first seven days following surgery, using a trajectory of pain scores at rest and upon exertion/deep breathing. Pain scores will be elicited from patients daily using the Pain Numeric Rating Scale.
Time frame: 48 hours postoperatively
Outcomes for opioid administration will evaluate the (a) frequency and (b) total consumption, defined as morphine equivalents, in the first 24 and 48 hours postoperatively. These will be captured based off medical record review.
Time frame: Postoperatively until discharge, an average of six days
Hospital length of stay will be defined as the number of days after surgery until the time of discharge from the hospital.
Time frame: Postoperatively until discharge, an average of 24 hours
Intensive Care Unit (ICU) length of stay will be calculated as the time from discharge from the initial index ICU stay minus the time of admission into the cardiovascular ICU and will be reported in hours.
Time frame: 30 days postoperatively
Hospital readmission will be evaluated within the first 30 days postoperatively using the Society for Thoracic Surgery database or via patient report during follow up phone calls.
Time frame: 30 days postoperatively
Major cardiac events will be evaluated within 30 days postoperatively and include stroke, atrial fibrillation and renal failure. These outcomes will be assessed using the Society for Thoracic Surgery database and medical record review.
Time frame: Postoperatively until discharge, an average of six days, and at 30, 180 and 365 days postoperatively
All-cause mortality will be assessed in-hospital and at 30, 180 and 365 days postoperatively. Mortality will be assessed using a combination of electronic medical record review, Society for Thoracic Surgery database, and family report during the follow up phone calls.
Contact information is provided by the study sponsor or research team.
Ariel Mueller, MA
CONTACT
Oluwaseun Johnson-Akeju, MD
CONTACT
Massachusetts General Hospital
Other
Acronym: MINDDS II
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07114458
Brain Diseases, Central Nervous System Diseases
Hamburg, Free and Hanseatic City of Hamburg, Germany
View Trial DetailsNCT05127265
Confusion, Critical Illness
Gainesville, Florida, United States
View Trial DetailsNCT07641153
Confusion, Delirium
Houston, Texas, United States
View Trial DetailsNCT06027788
Acute Kidney Injury, Arterial Occlusive Diseases
North Little Rock, Arkansas, United States
View Trial Details