The Impact of Dexmedetomidine Nasal Spray on Perioperative Anxiety in Neurosurgical Patients

ConditionsAnxiety Dexmedetomidine

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorBeijing Tiantan Hospital

About this trial

This randomized clinical trial aims to evaluate the effect of preoperative use of dexmedetomidine nasal spray on improving perioperative anxiety levels in patients undergoing elective supratentorial tumor resection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists physical status I to III

Scheduled to undergo elective supratentorial tumor resection

Preoperative STAI-S score >45

Obtain written informed consent

Disqualifiers

Severe hepatic or renal insufficiency

Allergy to dexmedetomidine or its excipients

Severe bradycardia (heart rate <50 bpm), sick sinus syndrome, or second-/third-degree AV block without pacemaker

Use of α2-agonists, benzodiazepines, or other sedatives/analgesics within 24 hours preoperatively

Trial design

Design model

Parallel

Treatments tested in this trial

Dexmedetomidine
Drug
Patients will receive dexmedetomidine nasal spray in the ward on the night before surgery (before bedtime) and on the morning of surgery (about 1 - 2 hours before anesthesia induction). When administering the drug, the patient should sit upright with the head slightly forward, shake well before use and pre-pray to activate the device. The standard dose is 100μg (2 sprays in each nostril, 4 sprays in total, 25 μg per spray). For subjects older than 60 years or weighing less than 45 kg, the dose is adjusted to 75 μg (a total of 3 sprays, alternately sprayed into both nostrils, for example, 2 sprays in the left nostril and 1 spray in the right nostril, or vice versa).

Treatment groups

114 Participants

are divided into 2 treatment groups

Group A: Dexmedetomidine nasal spray combined with routine perioperative managementActive comparator 1 intervention

Group B: Routine perioperative managementNo intervention 0 interventions

Trial outcomes

Primary outcomes

Difference in scores of the State-Trait Anxiety Inventory-State (STAI-S)

Difference in scores of the State-Trait Anxiety Inventory-State (STAI-S) from the preoperative baseline (1 day before surgery) to the 5th day after surgery.

Time frame

Postoperative 5 day

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: