NCT06579001

Brief Summary

Emergence Delirium (ED) is a common postoperative complication refers to an acute brain dysfunction that occurs during the recovery from general anesthesia, which is mainly characterized by sudden attention and consciousness disorders. The occurrence of ED increases the risk of self-injury, wound dehiscence, accidental catheter dislocation, and postoperative delirium, and is also associated with postoperative cognitive deterioration and increased utilization of medical resources after discharge.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

November 21, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2025

Completed
Last Updated

January 23, 2025

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

August 11, 2024

Last Update Submit

January 20, 2025

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

  • emergency delirium

    RASS\&CAM-ICU, delirium was judged according to whether there were positive features in the questionnaire

    postoperative

Secondary Outcomes (8)

  • Preoperative anxiety score

    preoperative

  • Postoperative delirium

    postoperative 3 days

  • time to extubation

    postoperative 3 days

  • PACU stay

    postoperative 3 days

  • Hemodynamic changes

    introperative

  • +3 more secondary outcomes

Study Arms (2)

Dex group

EXPERIMENTAL

at least 20 min before the introduction of anesthesia, the patient takes the sitting position, the head is slightly tilted forward, and the product is kept upright. Insert the nostril at the same Angle as the nasal cavity. Press down on the spray pump evenly with the index and middle fingers at the same time, and press the pump to the bottom at one time for 1 spray (25ug). After 1 spray on both nostrils, tilt your head back slightly and inhale gently. After staying for about 30 s, 1 spray was applied to each nostril on both sides for a total of 4 sprays (100ug).

Drug: Nasal spray dexmedetomidine

Saline group

PLACEBO COMPARATOR

Normal saline packaged in the same appearance was used

Drug: Nasal spray dexmedetomidine

Interventions

Nasal spray dexmedetomidineDRUG

Nasal spray dexmedetomidine or saline was used 100ug per patient acording to the group assignment

Also known as: saline
Dex groupSaline group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥60 years old
  • Total hip arthroplasty under general anesthesia
  • ASA II-III
  • Informed consent was obtained from patients or their guardians

You may not qualify if:

  • Allergy or contraindication to dexmedetomidine
  • Severe rhinitis and nasal deformity
  • Severe bradycardia (heart rate \<50 beats/minute) or atrioventricular block of grade 2 or higher, permanent pacemaker implantation, severe heart failure or ejection fraction \<30%
  • Patients with previous myocardial infarction, unstable angina pectoris, severe arrhythmia, and cardiac insufficiency
  • Emergency surgery
  • Severe hepatic and renal dysfunction (Child-Pugh class B and C, CKD3-5)
  • Preoperative mental illness, cognitive impairment, and communication difficulties could not be evaluated in the study
  • Preoperative delirium was present

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

闗闗

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Min Yan

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    STUDY DIRECTOR

Central Study Contacts

Min Yan

CONTACT

0571-87783759zryanmin@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2024

First Posted

August 30, 2024

Study Start

November 21, 2024

Primary Completion

March 31, 2025

Study Completion

April 8, 2025

Last Updated

January 23, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)