Moderate Sedation Combined With Acupuncture Anesthesia in Gastroscopy and Colonoscopy on Screening Research

Qingdao University

Status: Completed

Conditions: Gastrointestinal Endoscopy

Treatments: Drug: fentanyl; Drug: remimazolam; Drug: placebo needle; Procedure: eletroacupuncture(transcutaneous electrical acupuncture point stimulation )

Study type: Interventional

Funder types: Other

Identifiers

NCT05485064

QYFYKYLL 916711920

Details and patient eligibility

About

The purpose of this study is mainly about the feasibility and rationality of moderate sedation combined with acupuncture anesthesia in the application of gastroscopy and colonoscopy ,Then we evaluate the effectiveness and advantages of the combination of acupuncture anesthesia and drug anesthesia.

Full description

With the increase of the proportion of the patients who crave for performing painless gastroscopy and colonoscopy in recent years, it is crucial to seek a more secure and effective method of anesthesia or sedation. At present, the universal anesthetic method on gastroscopy and colonoscopy in China is the general anesthesia without intubation which usually uses propofol and opioid analgesics,Although the satisfaction of patients is high, the incidence of anesthesia-related complications and drug-related adverse reactions is high .The incidence of adverse events during the gastroscopy and colonoscopy is high, and the medical expense of anesthesia is high. At present, more than 2/3 of the patients undergo painless gastroscopy or colonoscopy are middle-aged and elderly patients, so the overdose which prolongs the recovery time、discharge time of patients and reduces the recovery quality of patients is common. The moderate sedation, which fundmentally does not affect hemodynamics、autonomous respiration and protective reflexes, is incomparable to general anesthesia . And acupuncture anesthesia also acts as a safe anesthetic method can provide safer analgesic effect.Theoretically，the combination of both of them is a relatively perfect and safe painless method.

Enrollment: 108 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Outpatients
2. Patients with ASA grade I-III
3. A sufficient level of education to understand study procedures and can communicate with investigators.

Exclusion criteria

1. Patients with serious systemic diseases such as severe cardiopulmonary disease or hepatic diseases or renal diseases.

2. Patients under the age of 18.

3. Patients who did not sign the informed consent form.

4. Patients who have a history of alcohol abuse or drug abuse.

5. People who are allergic to anesthetic related ingredients, such as soybeans, eggs and so on.

6. Patients with extreme fear or anxiety about acupuncture.

7. Patients with relative contraindications of gastrointestinal endoscopy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 3 patient groups

electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam

Experimental group

Description:

The investigator 1 combine electroacupuncture(transcutaneous acupoint electrical stimulation ) with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy.

Treatment:

Procedure: eletroacupuncture(transcutaneous electrical acupuncture point stimulation )

Drug: remimazolam

placebo needle and remimazolam

Experimental group

Description:

The investigator 1 combine placebo needle with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy.

Treatment:

Drug: placebo needle

Drug: remimazolam

fentanyl and remimazolam

Experimental group

Description:

The investigator 1 combine fentanyl with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy.

Treatment:

Drug: remimazolam

Drug: fentanyl