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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139926
• Other study ID #: 2023328
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2024
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

5. 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Dexmedetomidine 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

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 scale has a minimum score of 0 and a maximum score of 21. Higher scores indicate greater levels of anxiety or depression.	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