Health Trials

MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES)

ConditionsMajor Abdominal SurgeryPostoperative Delirium (POD)Sleep DisturbancesIntranasal Dexmedetomidine
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age65-90
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

This study aims to determine whether, compared with placebo, the nighttime self-administration of a nasal dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in high-risk patients.

Eligibility criteria

Qualifiers

Aged 65-90 years

Scheduled for a major abdominal surgery with estimated surgery time ≥ 2 hours

Disqualifiers

Blind, deafness or the inability to speak mandarin

Allergy to dexmedetomidine.

Renal and liver failure requiring dialysis or Child-Pugh score > 5

Follow-up difficulties (i.e. active substance abuse, psychotic disorder, homelessness)

Trial design

Treatments tested in this trial

  • Dexmedetomidine
  • Placebo

Treatment groups

400 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Sixth Affiliated Hospital, Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov