Dexmedetomidine Premedication for Post-anaesthesia Sleep Disturbance

NCT06281561 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: FirstAHXiamenU-YB
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn about the effect of preoperative nasal spry with dexmedetomidine on postoperative sleep disturbance in young to middle-aged women undergoing hysteroscopy. The main questions it aims to answer are:1) what is the incidence of postoperative sleep disturbance in unisex patients who receive propofol anesthesia. 2) The preventive effect of preanesthesia nasal spray dexmedetomidine on postoperative sleep disturbance. Participants will receive total intravenous propofol anaesthesia after dexmedetomidine nasal spray. Sleep quality will be monitored by using a Wearable devices and the PSQI which was used to assess sleep quality 1,2 days before the surgery and 1,3,7 days after surgery. Researchers will compare the effects of 0.2 or 0.5 ug/kg dexmedetomidine to see if it help improve postanesthesia sleep quality.

Conditions

Postoperative Sleep Disturbance

Keywords

Sleep Disturbance; Dexmedetomidine; Anesthesia; propofol

Outcome Measures

Primary Outcomes (2)

• Change from baseline sleep quality at after intervention

  Wearable devices continuously records Night sleep duration, deep sleep proportion, light sleep proportion, rapid eye movement (REM) proportion, deep sleep continuity, waking times, and breathing quality.All these parameters are registered and combined in a report that indicates the degree of quality of the person's sleep as good, fair or poor.

  1-2 day before and 7 days after anesthesia exposure

• Pittsburgh sleep quality index(PSQI)

  Total scores range from 0 to 21, with higher scores indicating worse sleep quality. PSQI≥8 was defined as sleep disorder.

  1 day or 2 days before anesthesia exposure and 1, 3, and 7 days after anesthesia exposure.

Secondary Outcomes (2)

• Early recovery evaluated by Aldrete rating scale

  Post anesthesia care unit time

• Later Recovery evaluated by QoR-40 questionnaire

  QoR-40 score on the third day after surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

Nasal spray with nomal saline before anesthesia

Drug: Normal Saline

Dexmedetomidine

EXPERIMENTAL

Nasal spray with dexmedetomidine before anesthesia

Drug: Dexmedetomidine

Interventions

Normal Saline DRUG

Female patients undergoing hysteroscopy receive nasal spray with normal saline before anesthesia

Control

Dexmedetomidine DRUG

Female patients undergoing hysteroscopy receive nasal spray with dexmedetomidine before anesthesia

Dexmedetomidine

Eligibility Criteria

• Age: 23 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing hysteroscopy in the hospital;2. American Society of Anesthesiologists Classification (ASA) I-II;3.No significant cardiovascular disease, liver, and kidney function within normal limits;4.Fully informed about the study and willing to participate by signing the informed consent form.

You may not qualify if:

• \. ASA III-IV, severe cardiovascular disease, or poor physical condition;2. History of mental illness;3. History of sedative or antipsychotic drug use (neuroinhibitors, anxiolytics, antidepressants, benzodiazepines) for any reason;4. History of sleep disorders or have night shifts;5. Surgical complications (bleeding, reoperation, meningitis);6. Nasal deformity or nasal trauma.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Related Publications (8)

• Wang X, Hua D, Tang X, Li S, Sun R, Xie Z, Zhou Z, Zhao Y, Wang J, Li S, Luo A. The Role of Perioperative Sleep Disturbance in Postoperative Neurocognitive Disorders. Nat Sci Sleep. 2021 Aug 6;13:1395-1410. doi: 10.2147/NSS.S320745. eCollection 2021.

  PMID: 34393534 BACKGROUND

• Purcell KF, Scarcella N, Chun D, Holland C, Stauffer TP, Bolognesi M, Lachiewicz P. Treating Sleep Disorders After Total Hip and Total Knee Arthroplasty. Orthop Clin North Am. 2023 Oct;54(4):397-405. doi: 10.1016/j.ocl.2023.05.008. Epub 2023 Jul 11.

  PMID: 37718079 BACKGROUND

• Yu S, Xiong Y, Lu G, Xiong X. Effects of Preoperative Sleep Disorders on Anesthesia Recovery and Postoperative Pain in Patients Undergoing Laparoscopic Gynecological Surgery under General Anesthesia. Mediators Inflamm. 2022 Dec 15;2022:7998104. doi: 10.1155/2022/7998104. eCollection 2022.

  PMID: 36570021 RESULT

• Jia X, Song Y, Li Z, Yang N, Liu T, Han D, Sun Z, Shi C, Zhou Y, Shi J, Liu Y, Guo X. Melatonin regulates the circadian rhythm to ameliorate postoperative sleep disorder and neurobehavioral abnormalities in aged mice. CNS Neurosci Ther. 2024 Mar;30(3):e14436. doi: 10.1111/cns.14436. Epub 2023 Sep 22.

  PMID: 37736695 RESULT

• Shi Y, Sun Q, Wang Y, Chen C, Jin J, Wang W, Lu Y, Hua Y, Liu J, Bian J, Yi Z. Can dexamethasone improve postoperative sleep and postoperative delirium in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy? Protocol for a prospective, randomized, double-blind, controlled study. Trials. 2023 Aug 8;24(1):505. doi: 10.1186/s13063-023-07521-8.

  PMID: 37550718 RESULT

• Zhang Y, Tan SL, Du J, Chen Y, Jia J, Feng JG, Liu KX, Zhou J. Dexmedetomidine alleviates neuroinflammation, restores sleep disorders and neurobehavioral abnormalities in rats with minimal hepatic encephalopathy. Int Immunopharmacol. 2021 Jul;96:107795. doi: 10.1016/j.intimp.2021.107795. Epub 2021 May 24.

  PMID: 34162157 RESULT

• De Zen L, Divisic A, Molinaro G, Solidoro S, Barbi E. Dexmedetomidine at Home for Intractable Dystonia and Insomnia in Children With Special Needs: A Case Series. J Pain Symptom Manage. 2023 Dec;66(6):e653-e657. doi: 10.1016/j.jpainsymman.2023.07.018. Epub 2023 Aug 5.

  PMID: 37544550 RESULT

• Li X, Yan L, Wang L, Chen H, Yang B. Study on the preventive effect of dexmedetomidine on anesthetic associated sleep disturbance in young to middle-aged female patients undergoing hysteroscopy: a study protocol for a crossover randomized controlled trial. Trials. 2024 Jul 15;25(1):480. doi: 10.1186/s13063-024-08311-6.

  PMID: 39010171 DERIVED

MeSH Terms

Conditions

Parasomnias

Interventions

Saline Solution; Dexmedetomidine

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• BIN YANG

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BIN YANG, Ph.D

CONTACT

+8613859986036; yangbin4332@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 28, 2024
• Study Start: May 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: February 2025