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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04691076
• Other study ID #: TYang001
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: December 2020
• Source: Tianjin Union Medical Center
• Contact: Tao Yang, Master
• Phone: 18920802290
• Email: yangtao[@]nankai.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Pain

Intervention

Drug:
• Propofol
Propofol is administered by target-controlled infusion
• Esketamine
Esketamine is intravenously administrated
• Fentanyl
Fentanyl is intravenously administrated

Locations

Country	Name	City	State
China	Tianjin Union Medical Center	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Union Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative propofol Consumption	Total amount of propofol administered intraoperatively	intraoperative
Secondary	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
Secondary	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)
Secondary	The incidence of side effects of esketamine	Record the adverse effects of esketamine such as dizziness, nausea, etc.	Intraoperative
Secondary	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
Secondary	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