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

NCT05485064 | Completed DMC

• 1 other identifier: QYFYKYLL 916711920
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Endoscopy

Keywords

eletroacupuncture; moderate sedation; remimazolam; transcutaneous electrical acupuncture point stimulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• the extent of cardia exposure

  During gastroscopy and colonoscopy

• adverse reactions

  During gastroscopy and colonoscopy

• patient's recovery time

  The end of gastroscopy and colonoscopy

• patient's departure time

  The end of gastroscopy and colonoscopy

• time to resume normal operation

  The end of gastroscopy and colonoscopy

Study Arms (3)

electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam

EXPERIMENTAL

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 ); Drug: remimazolam

placebo needle and remimazolam

EXPERIMENTAL

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

Drug: placebo needle; Drug: remimazolam

fentanyl and remimazolam

EXPERIMENTAL

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

Drug: fentanyl; Drug: remimazolam

Interventions

fentanyl DRUG

The investigator 1 use fentanyl to sedate patients coordinate with remimazolam

fentanyl and remimazolam

eletroacupuncture(transcutaneous electrical acupuncture point stimulation ) PROCEDURE

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

electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam

placebo needle DRUG

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

placebo needle and remimazolam

remimazolam DRUG

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

electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam; fentanyl and remimazolam; placebo needle and remimazolam

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients
• Patients with ASA grade I-III
• A sufficient level of education to understand study procedures and can communicate with investigators.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Jixiangyu

Qingdao, Shandong, 266000, China

Location

Related Publications (6)

• 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.

  PMID: 31968988 BACKGROUND

• 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.

  PMID: 35477483 BACKGROUND

• 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.

  PMID: 15173791 BACKGROUND

• 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.

  PMID: 31525334 BACKGROUND

• 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.

  PMID: 33691439 RESULT

• Xu JH, Tan HL, Zhang LN, Zhou ZG, Yuan L, Kong LX, Song MQ, Qi LJ, Ji XY. Transcutaneous Electrical Acupoint Stimulation Combined with Moderate Sedation of Remimazolam Tosilate in Gastrointestinal Endoscopy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Pain Ther. 2024 Aug;13(4):919-936. doi: 10.1007/s40122-024-00618-1. Epub 2024 Jun 18.

  PMID: 38890239 DERIVED

MeSH Terms

Interventions

Fentanyl; remimazolam

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 3, 2022
• Study Start: August 1, 2022
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

CN (1)