Dexmedetomidine Premedication for Post-anaesthesia Sleep Disturbance

April 14, 2024 updated by: Yang Bin, The First Affiliated Hospital of Xiamen University

Effect of Intranasal Dexmedetomidine Premedication on Sleep Disturbance After General Anaesthesia

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

General anesthesia induces a drug-dependent state of unconsciousness and disrupts the normal 90-minute cycles of non-REM and REM sleep, resulting in significant suppression of physiological sleep during the postoperative period. This can lead to complications such as daytime fatigue, anxiety, pain, and a significant impact on mental and cognitive function. Currently, no effective interventions have been identified to prevent postoperative sleep disturbance. Dexmedetomidine induces a distinct sedative response, with a easy transition from sleep to wakefulness and deep sedation similar to natural sleep, while maintaining forebrain connectivity. This has clinical implications for reducing postoperative sleep disturbances by exploring optimal combinations of anaesthetic drugs.

In this study, all subjects meeting the inclusion criteria will be randomly assigned to one of three groups: Dexmedetomidine 0.2 ug/kg, Dexmedetomidine 0.5 ug/kg and normal saline as control group. All dexmedetomidine solutions were diluted to 0.6ml at different doses and prepared by a senior nurse who was not involved in the follow-up. All patients received no preoperative medication. On arrival in the waiting room, all patients were examined and received an intranasal spray of a total volume of 0.6ml 25 minutes before anesthesia. Patients, anesthetists, gynecologists and nurses were all blinded to group allocation. Patients received an intravenous cannula with lactated Ringer's solution. Heart rate, non-invasive blood pressure, electrocardiogram, and SpO2 and BIS were monitored during hysteroscopic procedures. Propofol was administered via the TCI infusion system using the Marsh pharmacokinetic parameters with a target plasma concentration of 3.2 ng/ml in three groups. The initial starting dose of propofol was based on the results of our pre-test and BIS. If the target was achieved and the BIS was <50, remifentanil was given at 1 ug/kg by pump and LMA was then placed. During the hysteroscopy, TCI was regulated according to the up and down method of Dixon, first described in 1965. TCI was upregulated by 0.1-0.2 when patients had a somatic response （unintended movement of the angelus orris or limbs） during cervical dilation. In the absence of limb movement, the subsequent target plasma concentration was reduced by 0.1 ng/ml. Emergency equipment and drugs were available at all times.

Early recovery will be evaluated in PACU and Later recovery will be measured using QoR-40 questionnaire. Sleep quality was monitored using a wearable device and assessed using the Pittsburgh Sleep Quality Index questionnaire 1-2 days before surgery and 1, 3, and 7 days after surgery.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

1.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.

Exclusion Criteria:

1. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Nasal spray with nomal saline before anesthesia
Drug: Normal Saline
Female patients undergoing hysteroscopy receive nasal spray with normal saline before anesthesia
Experimental: Dexmedetomidine
Nasal spray with dexmedetomidine before anesthesia
Drug: Dexmedetomidine
Female patients undergoing hysteroscopy receive nasal spray with dexmedetomidine before anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline sleep quality at after intervention
Time Frame: 1-2 day before and 7 days after anesthesia exposure
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)
Time Frame: 1 day or 2 days before anesthesia exposure and 1, 3, and 7 days after anesthesia exposure.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early recovery evaluated by Aldrete rating scale
Time Frame: Post anesthesia care unit time
The total score is 10 points. Higher scores indicate better rehabilitation. When the patient's score was > 9, the patient could be considered for transfer out of PACU
Post anesthesia care unit time
Later Recovery evaluated by QoR-40 questionnaire
Time Frame: QoR-40 score on the third day after surgery
The maximum total score is 200, with higher scores indicating better recovery quality
QoR-40 score on the third day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Investigators

  • Principal Investigator: BIN YANG, The First Affiliated Hospital of Xiamen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstAHXiamenU-YB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We expect to release the original data on the ResMan original data sharing platform （IPD sharing platform）.

IPD Sharing Time Frame

February 2025

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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