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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Endoscopy
• Intervention / Treatment: Procedure: eletroacupuncture(transcutaneous electrical acupuncture point stimulation ); Drug: remimazolam; Drug: placebo needle; Drug: fentanyl

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Jixiangyu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: eletroacupuncture(transcutaneous electrical acupuncture point stimulation ); The investigator 1 use electroacupunture(transcutaneous electrical acupuncture point stimulation )to coordinate with remimazolam; Drug: remimazolam; The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle
EXPERIMENTAL: placebo needle and remimazolam; The investigator 1 combine placebo needle with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy.	Drug: remimazolam; The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle; Drug: placebo needle; The investigator 1 use placebo needle to sedate patients coordinate with remimazolam
EXPERIMENTAL: fentanyl and remimazolam; The investigator 1 combine fentanyl with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy.	Drug: remimazolam; The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle; Drug: fentanyl; The investigator 1 use fentanyl to sedate patients coordinate with remimazolam

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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2022
• Primary Completion (ACTUAL): November 3, 2022
• Study Completion (ACTUAL): November 3, 2022

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: July 31, 2022
• First Posted (ACTUAL): August 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: remimazolam; eletroacupuncture; moderate sedation; transcutaneous electrical acupuncture point stimulation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: QYFYKYLL 916711920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No