Actively Recruiting
Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients
Led by Harbin Medical University · Updated on 2025-06-04
280
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
H
Harbin Medical University
Lead Sponsor
F
First Affiliated Hospital of Harbin Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial is studying elderly patients aged 65 and above undergoing painless gastroscopy and colonoscopy to evaluate the use of remimazolam combined with esketamine as an opioid-free anesthesia (OFA) protocol. Researchers aim to determine if this new protocol is feasible and not inferior to the traditional opioid-containing anesthesia (OA) protocol using remimazolam combined with remifentanil. The study focuses on comparing sedation success and safety between these two anesthesia methods in elderly patients with gastrointestinal disease. Participants are randomly assigned to one of two groups: one group receives anesthesia with remimazolam combined with esketamine, while the other group receives remimazolam combined with remifentanil. Both groups receive initial doses adjusted by body weight during anesthesia induction, with additional doses given during the procedure according to sedation depth and patient movement. The protocol includes drugs such as lidocaine and changtonine alongside the main anesthetics. During the study, researchers will monitor respiratory and circulatory indicators, including oxygen saturation, respiratory rate, heart rate, blood pressure, and sedation levels from the start of anesthesia induction until the end of surgery. They will also record adverse events, recovery times, patient and doctor satisfaction, and cognitive assessments before and after the procedure. Follow-up assessments include telephone interviews and confusion evaluations up to seven days post-surgery to ensure safety and recovery. The trial is planned to continue until January 2028.
CONDITIONS
Brief Title
Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing painless gastroenteroscopy in outpatient clinics
- Aged 65 years and above
- American Society of Anesthesiologists (ASA) physical status grades I to III
You will not qualify if you...
- Abnormal liver or kidney function
- Known respiratory or endocrine diseases
- Uncontrolled hypertension and New York Heart Association (NYHA) classification II to III
- Taking monoamine oxidase inhibitors, sedatives, analgesics, hypnotics, antipsychotics, antiemetics, or antidepressants
- Addiction to tobacco or alcohol
- Allergy to the investigational drug
- Expected difficult airway
- Body mass index greater than 35 kg/m²
- Participation in other clinical trials within the past three months
- Psychosocial illness or cognitive dysfunction preventing cooperation or communication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the surgical procedure
Participants receive anesthesia with remimazolam combined with either esketamine or remifentanil during painless gastroenteroscopy procedures. Doses are adjusted during the operation based on sedation depth.
1 visit (in-person) on the day of the procedure
Duration - Up to 7 days after surgery
Participants are monitored after surgery for recovery, adverse reactions, pain, cognitive status, and satisfaction until they leave the anesthesia recovery room and during follow-up assessments up to 7 days after surgery.
1 visit immediately post-operation and 2 follow-up contacts (in-person or phone) over 7 days
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Actively Recruiting
Research Team
L
LIU Shujie LIU
S
SHI Xiaoqian SHI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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