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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
108
The investigator 1 use fentanyl to sedate patients coordinate with remimazolam
The investigator 1 use electroacupunture(transcutaneous electrical acupuncture point stimulation )to coordinate with remimazolam
The investigator 1 use placebo needle to sedate patients coordinate with remimazolam
Jixiangyu
Qingdao, Shandong, China
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).
Time frame: 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).
Time frame: 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).
Time frame: During gastroscopy and colonoscopy
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%)
Time frame: 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.
Time frame: During gastroscopy and colonoscopy
patient's recovery time
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle
The investigator 2 needs to record to evaluate patient's recovery quality about patients
Time frame: 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
Time frame: 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
Time frame: The end of gastroscopy and colonoscopy
operation time about gastrointestinal endoscopy
The investigator 2 needs to record operation time about gastrointestinal endoscopy.
Time frame: 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)
Time frame: 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%)
Time frame: 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)
Time frame: 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)
Time frame: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy