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

NCT06139926 | Recruiting Phase 3

• 1 other identifier: 2023328
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dexmedetomidine administered intravenously

OTHER

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

Dexmedetomidine administered intranasally

EXPERIMENTAL

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

Interventions

Dexmedetomidine administered intranasally DRUG

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.

Dexmedetomidine administered intranasally; Dexmedetomidine administered intravenously

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: cinical investigator

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

CN (1)