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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Dexmedetomidine administered intranasally

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • The First Affiliated Hospital of Chongqing Medical University
      • Contact: Sixu Lai; Phone Number: +8613541186640; Email: 1138881730@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dexmedetomidine administered intravenously; 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; 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.
Experimental: Dexmedetomidine administered intranasally; 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; 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.

What is the study measuring?

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 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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 2023328

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No