Clinical trial NCT05485064: Moderate Sedation Combined With Acupuncture Anesthesia in Gastroscopy and Colonoscopy on Screening Research
Official title: Moderate Sedation Combined With Acupuncture Anesthesia in Gastroscopy and Colonoscopy on Screening Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Endoscopy
Keywords: eletroacupuncture
moderate sedation
remimazolam
transcutaneous electrical acupuncture point stimulation
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

   -

Primary outcomes:
measure: patient satisfaction with sedation instrument，PSSI
timeFrame: During gastroscopy and colonoscopy
measure: clinical satisfaction with sedation instrument，CSSI
timeFrame: During gastroscopy and colonoscopy
measure: patient's pain score
timeFrame: During gastroscopy and colonoscopy
Secondary outcomes:
measure: the extent of cardia exposure
timeFrame: During gastroscopy and colonoscopy
measure: adverse reactions
timeFrame: During gastroscopy and colonoscopy
measure: patient's recovery time
timeFrame: The end of gastroscopy and colonoscopy
measure: patient's departure time
timeFrame: The end of gastroscopy and colonoscopy
measure: time to resume normal operation
timeFrame: The end of gastroscopy and colonoscopy
measure: operation time about gastrointestinal endoscopy
timeFrame: During gastroscopy and colonoscopy
measure: heart rate
timeFrame: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy
measure: pulse oximetry
timeFrame: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy
measure: systolic pressure 、diastolic pressure
timeFrame: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy
measure: respiratory rate
timeFrame: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Jixiangyu
state: Shandong
Study officials:
References:
citation: Eberl S, Monteiro de Olivera N, Bourne D, Streitberger K, Fockens P, Hollmann MW, Preckel B. Effect of electroacupuncture on sedation requirements during colonoscopy: a prospective placebo-controlled randomised trial. Acupunct Med. 2020 Jun;38(3):131-139. doi: 10.1136/acupmed-2017-011459. Epub 2020 Jan 22.
citation: Yu B, Hazlewood PJ, Yin X, Li S, Yue H, Xu K, Xu S, Mi Y. Effect of electroacupuncture on discomfort during gastroscopy: a study protocol for a randomized controlled trial. Trials. 2022 Apr 27;23(1):364. doi: 10.1186/s13063-022-06165-4.
citation: Cohen LB, Hightower CD, Wood DA, Miller KM, Aisenberg J. Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam. Gastrointest Endosc. 2004 Jun;59(7):795-803. doi: 10.1016/s0016-5107(04)00349-9.
citation: Qin Z, Ding Y, Xu C, Kwong JSW, Ji Y, Wu A, Wu J, Liu Z. Acupuncture vs Noninsertive Sham Acupuncture in Aging Patients with Degenerative Lumbar Spinal Stenosis: A Randomized Controlled Trial. Am J Med. 2020 Apr;133(4):500-507.e20. doi: 10.1016/j.amjmed.2019.08.038. Epub 2019 Sep 13.
citation: Chen JM, Li DD, Chen YS, Lian B, Wang XP, Guo YH, Xu XL, Huang P, Chen TF, Liu Y, Liu QQ. The effectiveness of electro-acupuncture combined with dyclonine hydrochloride in relieving the side effects of gastroscopy: a controlled trial. Ann Palliat Med. 2021 Mar;10(3):2958-2970. doi: 10.21037/apm-20-831. Epub 2021 Mar 1.