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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-11-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastrointestinal Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

During the examination, the acupuncture position was blocked to ensure that the acupuncture position was not visible; except for researcher 1, the only researcher who knew about the grouping of patients,All trial-related data were recorded by researcher 2 , and researcher 1 was responsible for patients'sedation.

Study Groups

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electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam

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

Group Type EXPERIMENTAL

eletroacupuncture(transcutaneous electrical acupuncture point stimulation )

Intervention Type PROCEDURE

The investigator 1 use electroacupunture(transcutaneous electrical acupuncture point stimulation )to coordinate with remimazolam

remimazolam

Intervention Type DRUG

The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle

placebo needle and remimazolam

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

Group Type EXPERIMENTAL

placebo needle

Intervention Type DRUG

The investigator 1 use placebo needle to sedate patients coordinate with remimazolam

remimazolam

Intervention Type DRUG

The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle

fentanyl and remimazolam

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

Group Type EXPERIMENTAL

fentanyl

Intervention Type DRUG

The investigator 1 use fentanyl to sedate patients coordinate with remimazolam

remimazolam

Intervention Type DRUG

The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle

Interventions

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fentanyl

The investigator 1 use fentanyl to sedate patients coordinate with remimazolam

Intervention Type DRUG

eletroacupuncture(transcutaneous electrical acupuncture point stimulation )

The investigator 1 use electroacupunture(transcutaneous electrical acupuncture point stimulation )to coordinate with remimazolam

Intervention Type PROCEDURE

placebo needle

The investigator 1 use placebo needle to sedate patients coordinate with remimazolam

Intervention Type DRUG

remimazolam

The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle

Intervention Type DRUG

Eligibility Criteria

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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.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes