MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    Intranasal dexmedetomidine (100 µg total: 4 sprays, 25 µg/spray; Hengrui Medicine, China) self-administered preoperatively (\~9 PM) and optionally on the night of surgery (patient decides dose: 0, 2 sprays, or 4 sprays).

  • Placebo

    Drug

    Intranasal water for injection (4 sprays, identical volume as nasal dexmedetomidine; Hengrui Medicine, China) self-administered preoperatively (\~9 PM) and optionally on the night of surgery (patient decides dose: 0, 2 sprays, or 4 sprays).

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: DexmedetomidineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of postoperative delirium

Confusion Assessment Method

Time frame
Up to postoperative day (POD) 7 or discharge (whichever first).

Secondary outcomes

1

Delirium severity

Confusion Assessment Method Score

Time frame
Up to postoperative day (POD) 7 or discharge (whichever first)
2

Physical activity

Fitbit Flex2 tracker

Time frame
Up to postoperative day (POD) 3
3

Sleep quality

Fitbit Flex2 tracker and Athens Insomnia Scale

Time frame
Up to postoperative day (POD) 3
4

Anxiety

Hamilton Anxiety Scale

Time frame
Up to postoperative day (POD) 3

Other outcomes

1

Optional intranasal administration on the night of surgery

Optional intranasal administration of the same spray (patient decides dose: 0, 2 sprays, or 4 sprays)

Time frame
At night of the surgery
2

Length of Hospital Stay

Medical Record Review

Time frame
From postoperative day 0 until date of hospital discharge (Up to 30 days)
3

Cognitive function

Abbreviated Mental Test Score

Time frame
Up to postoperative day (POD) 30

Locations

This trial has no locations.

Sponsors and contacts

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