Effect of Low-dose Esketamine Combined With Target-controlled Infusion of Propofol for Painless Gastrointestinal Endoscopy

Efficacy and Safety of Low-dose Esketamine Combined With Target-controlled Infusion of Propofol for Painless Gastrointestinal Endoscopy and Polypectomy

Purpose: 1. To determine the efficacy of low-dose esketamine in painless gastrointestinal endoscopy. 2. To determine the safety of low-dose esketamine in painless gastrointestinal endoscopy. 3. To provide a theoretical basis and new ideas for the application of esketamine as a new drug in perioperative period.

Study Overview

• Status: Unknown
• Conditions: Pain; Anesthesia
• Intervention / Treatment: Drug: Propofol; Drug: Esketamine; Drug: Fentanyl

Detailed Description

Keeping spontaneous breathing anesthesia can provide patients with comfortable diagnosis and treatment experience during gastrointestinal endoscopy, which is a vital prerequisite for the large-scale development of this operation as well as the early screening and treatment of gastrointestinal malignancies. Clinically, fentanyl combined with propofol is the most commonly used anesthesia regimen for the painless gastroscopy, however its high incidence of respiratory and circulatory depression will threaten the safety of patients. Instead, esketamine has a good action in anesthesia and analgesics, a slighter respiratory depression, as well as with a remarkable improvement in adverse effects than ketamine. What has already been proved is that low- dose of esketamine can remarkably reduce the dosage of propofol during endoscopic retrograde cholangiopancreatography; In our pilot study, we found that not only the incidence of respiratory depression was significantly lower than that of fentanyl during endoscopic polypectomy, but also the dosage of propofol was reduced at the same time,suggesting that esketamine may have a potential superiority in the painless gastrointestinal endoscopy.Our project plans to collect the patients who have received painless gastroscopy and polypectomy in the hospital, and use a target-controlled infusion (TCI) of propofol in combination with esketamine, by observing the total dose of propofol , the time of recovery and the length of hospital stay, the satisfaction of patients and endoscopists, drug side effects,adverse events of respiratory and circulatory system and other indicators ,to evaluate the efficacy and safety of this anesthetic scheme.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Yang, Master; Phone Number: +86-10 18920802290; Email: yangtao@nankai.edu.cn

Study Locations

• China
  • Tianjin, China, 300131
    • Recruiting
    • Tianjin Union Medical Center
    • Contact: Tao Yang, Master; Phone Number: +86-10 18920802290; Email: yangtao@nankai.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject's American Society of Anesthesiologists physical status is I-III.
2. Subject has no symptoms of allergy to anesthetics.
3. Subject has no contraindications for gastrointestinal endoscopy.
4. Subject has given written informed consent to participate.

Exclusion Criteria:

1. Subject's BMI <18 or >30
2. Subject has poorly controlled or untreated hypertension.
3. Subject has severe ischemic heart disease.
4. Subject is an untreated or undertreated patient with hyperthyroidism.
5. Subject has used drugs that affect their central nervous system.
6. .Subject has mental illness.
7. .Subject has epilepsy.
8. .Subject has a history of chronic pain.
9. .Subject is pregnant or breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Propofol/Esketamine sedation; Propofol target-controlled infusion is performed first,when the infusion concentration reaches 1.5μg/ml,esketamine 0.15mg/kg is injected intravenously;then the dose is adjusted according to the depth of anesthesia and the modified observer's assessment of alert /sedation scale, and propofol target-controlled infusion for every increase of 5μg/ml in concentration, the corresponding increase of esketamine is 0.05mg/kg; the total dose of esketamine used in surgery shall not exceed 0.5mg/kg.	Drug: Propofol; Propofol is administered by target-controlled infusion; Drug: Esketamine; Esketamine is intravenously administrated
ACTIVE_COMPARATOR: Propofol/Fentanyl sedation; Propofol target-controlled infusion is performed first.When the infusion concentration reaches 1.5μg/ml, fentanyl 0.6μg/kg is injected intravenously; then the dose is adjusted according to the depth of anesthesia and the modified observer's assessment of alert /sedation scale, and propofol target-controlled infusion for every increase of 5μg/ml in concentration,the corresponding increase of fentanyl is 0.2ug/kg; the total dose of fentanyl used in surgery shall not exceed 1.2ug/kg.	Drug: Propofol; Propofol is administered by target-controlled infusion; Drug: Fentanyl; Fentanyl is intravenously administrated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative propofol Consumption	Total amount of propofol administered intraoperatively	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of adverse events in pulmonary and circulatory systems	Pulmonary incidents include:Decreased blood oxygen saturation (SpO2 drops to 75%~90%, duration <60s);Severe decrease in blood oxygen saturation (SpO2<90%, duration>60s; or SpO2<75%);Obstruction of the airways occurs and requires the use of jaw manipulation or emergency airway equipment. Cardiovascular incidents include: Bradycardia or tachycardia; Arterial blood pressure increased or decreased by more than 20% of the baseline; Other matters requiring urgent attention.	During the operation
Time of recovery, post-anaesthesia care unit and discharge from hospital	When the patient is successfully resuscitated,record the time in post-anaesthesia care unit and the time when the discharge standards are met.	procedure ( the end of endoscopy removal)
The incidence of side effects of esketamine	Record the adverse effects of esketamine such as dizziness, nausea, etc.	Intraoperative
The number of patients'body movement during operation	Record the patient's body movement during the operation, which reflects the level of sedation.	During the operation
The satisfaction of the endoscopist and patient	Patients fill out questionnaires before and after surgery to record pain, sedation levels, and side effects (such as nausea and dizziness) to assess their satisfaction,meanwhile,telephone calls can be made one day after the surgery to evaluate their postoperative satisfaction.In addition, the satisfaction of the endoscopist with the sedation level could also recorded on a questionnaire after the operation.	24 hours after surgery

Collaborators and Investigators

• Sponsor: Tianjin Union Medical Center
• Investigators: Principal Investigator: Tao Yang, Tianjin Union Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): February 1, 2022

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (ACTUAL): December 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Esketamine; Gastrointestinal endoscopy; Analgesia; Sedation; Respiratory depression
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Psychotropic Drugs; Antidepressive Agents; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Propofol; Esketamine
• Other Study ID Numbers: TYang001

Drug and device information, study documents

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