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Trial Title:
Effect of Esketamine on Anxiety State in Patients Undergoing Abdominal Tumor Surgery
NCT ID:
NCT06530706
Condition:
Anxiety State
Esketamine
Conditions: Official terms:
Abdominal Neoplasms
Anxiety Disorders
Esketamine
Conditions: Keywords:
esketamine
anxiety state
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Esketamine
Description:
Esketamine 0.2mg/kg was pumped slowly after intubation, followed by 0.1mg/kg pumped until
the end of the operation. In the PCIA pump, esketamine 1mg/kg was added to the
sufentanil.
Arm group label:
Experiment group
Other name:
Experimental group
Intervention type:
Drug
Intervention name:
normal saline
Description:
Same volume of normal saline was pumped slowly after intubation, followed by the same
volume of NS until the end of the operation. In the PCIA pump, only sufentanil was used.
Arm group label:
Control group
Other name:
Control Group
Summary:
To evaluate whether esketamine can relieve anxiety in patients undergoing abdominal tumor
surgery.
Detailed description:
Hamilton anxiety Scale was used to screen patients with anxiety. Only patients with score
≥ 8 were enrolled. These patients were randomly assigned to the experimental group and
control group.
All patients enrolled were evaluated with Hamilton anxiety Scale, PHQ-8 scale, QoR-15
Scale and Athens Insomnia Scale. After induction, sevoflurane and remifentanil were used
to maintain anesthesia. The experimental group had esketamine while the control group had
normal saline. Athens Insomnia Scale was used to assess the sleep status 1, 2, 3 days
after surgery and 1 month after surgery. Hamilton anxiety Scale was used to evaluate the
anxiety state of the patients 3 days after surgery and 1 month after surgery. PHQ-8
scale, QoR-15 Scale were collected 3 days after surgery and 1 month after surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients undergoing abdominal tumor surgery;
- older than 18 years old and younger than 70 years old;
- ASA grade I-III；
- Hamilton anxiety scale ≥ 8.
Exclusion Criteria:
- Having serious mental illness before surgery or on antipsychotic medication at the
time of surgery;
- Severe organ function lesions such as heart failure (left ventricular ejection
fraction <30%), myocardial infarction, kidney failure (requiring kidney replacement
therapy), liver function impairment (Child-Pugh grade C), etc.
- Patients arranged to receive general anesthesia combined with epidural anesthesia
patients;
- Patients who cannot communicate, read or write due to visual, auditory, language or
other reasons;
- Patients allergic to ketamine;
- Patients refused to use postoperative self-controlled intravenous analgesia pump;
- Patients refused to participate in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang cancer hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Wen Zhang
Phone:
15990145873
Email:
wendymos@126.com
Start date:
August 5, 2024
Completion date:
September 20, 2025
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06530706
