To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Study of Dexmedetomidine Administered Intranasally to Relieve Perioperative Anxiety and Depression in Patients With Colorectal Tumors
NCT ID:
NCT06139926
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Dexmedetomidine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Dexmedetomidine administered intranasally
Description:
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.
Arm group label:
Dexmedetomidine administered intranasally
Arm group label:
Dexmedetomidine administered intravenously
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Sixu Lai
Phone:
+8613541186640
Email:
1138881730@qq.com
Start date:
December 1, 2023
Completion date:
June 1, 2024
Lead sponsor:
Agency:
First Affiliated Hospital of Chongqing Medical University
Agency class:
Other
Source:
First Affiliated Hospital of Chongqing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06139926
