Preoperative anxiety in patients undergoing gynecological laparoscopic surgery
Conditions
Interventions
Experimental group:Dexmedetomidine nasal spray 100 µg, intranasal administration, 4 sprays in total.
control group:Intranasal administration of an equal volume of 0.9% sodium chloride solution before surgery.
Sponsors
Huai'an First People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients scheduled for gynecological laparoscopic surgery; 2.Female, aged 18 to 65 years; 3.ASA classification of grade I to III; 4.Able to cooperate with the completion of the scale assessment and routine perioperative monitoring as stipulated in this study; 5.Able to fully understand the methods and procedures of this study and willing to abide by the research protocol, and voluntarily sign the informed consent form; 6.Screening for State Anxiety Inventory (SAI) before administration of medication = 45 points; 7.Facial video collection is an optional sub-study content. Even if the subject does not agree to video collection, they can still enter the main trial and complete the primary endpoint and other routine outcome assessments; only when they agree to participate in the video sub-study, is it required that the facial collection area is unobstructed and the corresponding video recording can be completed.
Exclusion criteria
Exclusion criteria: 1.For the facial video sub-study, those with any neurological disorders or related diseases that may affect the movement of facial expression muscles will not be included in the video collection and analysis; however, if they meet the other conditions of the main experiment, they can still be included in the main experiment. 2.Those who cannot understand the research process, cannot complete the scale assessment, or cannot cooperate with the routine monitoring during the perioperative period; 3.Emergency surgeries, those who need immediate sedation before entering the operating room, or those whose research process will significantly delay clinical treatment; 4.Those who have participated in other interventional clinical studies within the past 3 months and the researcher judges that it may affect safety or the main outcome; 5.Those who have a clear severe allergic history to dexmedetomidine, 0.9% sodium chloride solution, spray equipment materials, electrode materials, or related materials; 6.Those with significant bradycardia at baseline (such as HR < 50 beats per minute), second-degree or higher atrioventricular conduction block without pacing protection, symptomatic hypotension, SBP < 90 mmHg, severe arrhythmia, or other conditions that the researcher judges may not be suitable for receiving dexmedetomidine; 7.Those with active severe rhinitis, obvious nasal obstruction, repeated nosebleeds, recent nasal surgery, or other conditions that may significantly affect the absorption and safety of nasal administration; 8.Those who are pregnant, breastfeeding, or the researcher judges that there is a possibility of pregnancy and has not completed the routine hospital assessment; 9.Those who use non-scheme sedatives, anti-anxiety drugs, opioids, or a2 receptor agonists within 24 hours, and cannot record or control them; 10.Those with severe liver, kidney, heart, or lung dysfunction or respiratory failure, or those with obvious diseases that increase the risk of sedation or hypoxia; 11.Those with abnormal hypothalamic, anterior pituitary, gonadal, or adrenal functions; 12.Those with a history of smoking or alcohol abuse; 13.Those with difficult-to-control mental and psychological diseases; 14.Those with acute or chronic infections; 15.Those with severe diseases of important organs such as the heart, lung, liver, and kidney; 16.Those with autoimmune diseases; 17.Those with a family history of genetic diseases; 18.Those with neurological diseases; 19.Those who cannot adhere to follow-up; 20.Those who, in the researcher's opinion, are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in State Anxiety Inventory-State score from T0 to T2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale for Anxiety (VAS-A);Amsterdam Preoperative Anxiety and Information Scale (APAIS);Modified Observer’s Assessment of Alertness/Sedation Scale score;Blood pressure;Heart rate;Peripheral oxygen saturation (SpO2);Adverse events and serious adverse events;Heart rate variability (Root Mean Square of Successive Differences, RMSSD);Facial-expression dynamic features;Numeric Rating Scale (NRS);Quality of Recovery-15 (QoR-15);Patient satisfaction; | — |
Countries
China
Contacts
Public ContactCheng Wei
Huai'an First People's Hospital
Outcome results
None listed