Clinical Study of Dexmedetomidine Administered Intranasally to Relieve Perioperative Anxiety and Depression in Patients With Colorectal Tumors

Study Overview
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Brief Summary
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Currently, domestic and international research on dexmedetomidine as well as anxiety and depression is more focused on basic research. In terms of clinical research, dexmedetomidine is more often used in pediatrics, short surgeries, intensive care units, etc., for sedation and analgesia; while less research has been done for the relief of anxiety and depression. At present, on the one hand, the number of oncology patients is on the rise both at home and abroad, and on the other hand, anxiety and depression account for an increasing proportion of healthcare in the world. Tumor patients, as a high prevalence group of anxiety and depression, their prognosis and regression are also more complicated. Therefore, exploring the role of intranasal administration of dexmedetomidine in relieving perioperative anxiety and depression in oncology patients has a very strong practical basis and clinical significance.

Official Title
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Clinical Study of Dexmedetomidine Administered Intranasally to Relieve Perioperative Anxiety and Depression in Patients With Colorectal Tumors

Conditions
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Relieving Perioperative Anxiety and Depression in Colorectal Cancer Patients

Intervention / Treatment
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* Drug: Dexmedetomidine administered intranasally


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Patients with a preoperative diagnosis of colorectal cancer who were to undergo their first oncologic procedure (2) Patients who opted for general anesthesia via orotracheal intubation (3) Age ≥18 years old (4) ASA classification II-III (5) 18.0 < BMI < 30.0 (6) Signed informed consent. Exclusion Criteria: (1) Diagnosed mental illness or cognitive impairment, or taking antipsychotic, sedative-hypnotic, or anxiolytic-depressant medications (2) Serious abnormalities of liver or kidney function. (3) Prior alcohol or drug abuse (4) Second or third degree atrioventricular block, severe sinus bradycardia (<50 beats/min), sick sinus node syndrome, congenital heart disease, and other cardiac arrhythmias that severely affect hemodynamic stability (5) Grade 3 hypertension (6) Any disease of the head, such as cerebral infarcts, epilepsy, head trauma, etc. (7) Confirmed diagnosis of non-tumor-induced chronic ( ≥3 months) neuropathic pain (8) Inability to understand the meaning of the scale and complete the scoring. (9) Women preparing for pregnancy, pregnant women, or breastfeeding (10) Patients with myasthenia gravis (11) Respiratory function score ≥3

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dexmedetomidine administered intravenously<br>Dexmedetomidine was administered intravenously 15 min prior to patient induction (concentration 4 μg/ml; loading dose 1 μg/kg for 15 min; maintenance dose: 0.2 μg/(kg.h) until surgical specimen removal). | Drug: Dexmedetomidine administered intranasally<br>* Intranasal administration of dexmedetomidine (plain) was given at the bedside of the ward as per the pre-tested recommended dose. The patient's vital signs were maintained. On the day of surgery, 30 min before induction of anesthesia, intranasal dexmedetomidine (original solution) was administered in the operating room at the pre-tested recommended dose.<br>|
| Experimental: Dexmedetomidine administered intranasally<br>Intranasal administration of dexmedetomidine (original solution) was given at the bedside of the ward as per the pre-tested recommended dose. The patient's vital signs were maintained. On the day of surgery, 30 min before induction of anesthesia, intranasal dexmedetomidine (original solution) was administered in the operating room at the pre-tested recommended dose. | Drug: Dexmedetomidine administered intranasally<br>* Intranasal administration of dexmedetomidine (plain) was given at the bedside of the ward as per the pre-tested recommended dose. The patient's vital signs were maintained. On the day of surgery, 30 min before induction of anesthesia, intranasal dexmedetomidine (original solution) was administered in the operating room at the pre-tested recommended dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in perioperative HADS scale scores. | The first HADS scale score was performed at preoperative follow-up, and multiple HADS scale scores were performed within 30 days of surgery to observe changes in scores | The first HADS scale score was performed at preoperative follow-up, and multiple HADS scale scores were performed within 30 days of surgery to observe changes in scores |