RecruitingPhase 3NCT06139926

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


Sponsor

First Affiliated Hospital of Chongqing Medical University

Enrollment

126 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Patients with a preoperative diagnosis of colorectal cancer who were to undergo their first oncologic procedure
  • Patients who opted for general anesthesia via orotracheal intubation
  • Age ≥18 years old
  • ASA classification II-III (5) 18.0 \< BMI \< 30.0
  • Signed informed consent.

Exclusion Criteria11

  • Diagnosed mental illness or cognitive impairment, or taking antipsychotic, sedative-hypnotic, or anxiolytic-depressant medications
  • Serious abnormalities of liver or kidney function.
  • Prior alcohol or drug abuse
  • 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
  • Grade 3 hypertension
  • Any disease of the head, such as cerebral infarcts, epilepsy, head trauma, etc.
  • Confirmed diagnosis of non-tumor-induced chronic ( ≥3 months) neuropathic pain
  • Inability to understand the meaning of the scale and complete the scoring.
  • Women preparing for pregnancy, pregnant women, or breastfeeding
  • Patients with myasthenia gravis
  • Respiratory function score ≥3

Interventions

DRUGDexmedetomidine administered intranasally

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.


Locations(1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

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NCT06139926


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