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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

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

Conditions
-----------------
Gastrointestinal Endoscopy

Intervention / Treatment
-----------------
* Drug: fentanyl
* Procedure: eletroacupuncture(transcutaneous electrical acupuncture point stimulation )
* Drug: placebo needle
* Drug: remimazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients Patients with ASA grade I-III A sufficient level of education to understand study procedures and can communicate with investigators. Exclusion Criteria: Patients with serious systemic diseases such as severe cardiopulmonary disease or hepatic diseases or renal diseases. Patients under the age of 18. Patients who did not sign the informed consent form. Patients who have a history of alcohol abuse or drug abuse. People who are allergic to anesthetic related ingredients, such as soybeans, eggs and so on. Patients with extreme fear or anxiety about acupuncture. Patients with relative contraindications of gastrointestinal endoscopy. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam<br>The investigator 1 combine electroacupuncture(transcutaneous acupoint electrical stimulation ) with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. | Procedure: eletroacupuncture(transcutaneous electrical acupuncture point stimulation )<br>* The investigator 1 use electroacupunture(transcutaneous electrical acupuncture point stimulation )to coordinate with remimazolam<br>Drug: remimazolam<br>* The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle<br>|
| Experimental: placebo needle and remimazolam<br>The investigator 1 combine placebo needle with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. | Drug: placebo needle<br>* The investigator 1 use placebo needle to sedate patients coordinate with remimazolam<br>Drug: remimazolam<br>* The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle<br>|
| Experimental: fentanyl and remimazolam<br>The investigator 1 combine fentanyl with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. | Drug: fentanyl<br>* The investigator 1 use fentanyl to sedate patients coordinate with remimazolam<br>Drug: remimazolam<br>* The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction with sedation instrument，PSSI | The investigator 2 needs to use VAS scores to evaluate satisfaction about sedation feeling when they accepted gastroscopy and colonoscopy .The score ranges from 0 to10 and need patients evaluate it by themself when the gastroscopy or colonoscopy were finished.The score from 0 （extremely dissatisfied）to 10（extremely satisfied）. | During gastroscopy and colonoscopy | 
| clinical satisfaction with sedation instrument，CSSI | The investigator 2 needs to use VAS scores to evaluate satisfaction about doctors when they carry out the operation.The score from 0 （extremely dissatisfied）to 10（extremely satisfied）. | During gastroscopy and colonoscopy | 
| patient's pain score | The investigator 2 needs to use VAS scores to evaluate patients' pain score .The score from 0 （extremely dissatisfied）to 10（extremely satisfied）. | During gastroscopy and colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the extent of cardia exposure | The investigator 2 needs to record the extent of cardia exposure to evaluate these interventions'effect on gastroscopy ，the investigator 2 use the table of the extent of preventriculus exposure（score from 1 to 4，1=the extent of exposure lower than 25%；2=the extent of exposure between 25% and 50%；3=the extent of exposure between 50%and 75%；4=the extent of exposure between 75%and 100%） | During gastroscopy and colonoscopy | 
| adverse reactions | The investigator 2 needs to record the adverse reactions such as nausea、emesis, salivation, restlessness, and breath holding to analyze efficacy of relate treatment. | During gastroscopy and colonoscopy | 
| patient's recovery time | The investigator 2 needs to record to evaluate patient's recovery quality about patients | The end of gastroscopy and colonoscopy | 
| patient's departure time | The investigator 2 needs to record patient's departure time to evaluate recovery quality about patients | The end of gastroscopy and colonoscopy | 
| time to resume normal operation | The investigator 2 needs to record the time to resume normal operation about patient | The end of gastroscopy and colonoscopy | 
| operation time about gastrointestinal endoscopy | The investigator 2 needs to record operation time about gastrointestinal endoscopy. | During gastroscopy and colonoscopy | 
| heart rate | The investigator 2 needs to record heart rate（for example 60 times/min）before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（tachycardia：heart rate is more than 100 times/min；bradycardia：heart rate is less than 60 times/min） | before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy | 
| pulse oximetry | The investigator 2 needs to record pulse oximetry (for example 97% )before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（hypoxemia：pulse oximetry is lower than 90%） | before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy | 
| systolic pressure 、diastolic pressure | The investigator 2 needs to record systolic pressure 、diastolic pressure(for example 120/75mmHg ) before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（hypertension：systolic pressure ≥140mmHg or diastolic pressure ≥90mmHg；hypotension：systolic pressure ≤90mmHg or diastolic pressure ≤60mmHg） | before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy | 
| respiratory rate | The investigator 2 needs to record respiratory rate(for example 15 times/min)before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（tachypnea：respiratory rate is more than 20 times/min；bradypnea：respiratory rate is less than 12 times/min） | before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eletroacupuncture, moderate sedation, remimazolam, transcutaneous electrical acupuncture point stimulation