Clinical trial NCT06281561: Dexmedetomidine Premedication for Post-anaesthesia Sleep Disturbance
Official title: Effect of Intranasal Dexmedetomidine Premedication on Sleep Disturbance After General Anaesthesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Postoperative Sleep Disturbance
Keywords: Sleep Disturbance
Dexmedetomidine
Anesthesia
propofol
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 110
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline sleep quality at after intervention
timeFrame: 1-2 day before and 7 days after anesthesia exposure
measure: Pittsburgh sleep quality index(PSQI)
timeFrame: 1 day or 2 days before anesthesia exposure and 1, 3, and 7 days after anesthesia exposure.
Secondary outcomes:
measure: Early recovery evaluated by Aldrete rating scale
timeFrame: Post anesthesia care unit time
measure: Later Recovery evaluated by QoR-40 questionnaire
timeFrame: QoR-40 score on the third day after surgery
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Xiamen University
name: BIN YANG
role: PRINCIPAL_INVESTIGATOR
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