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Completed

NCT Number: NCT05485064

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.

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Key information

Conditions

Gastrointestinal Endoscopy

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jixiangyu

Qingdao, Shandong, 266000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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Treatment and study plan

Fentanyl

Drug

The investigator 1 use fentanyl to sedate patients coordinate with remimazolam

eletroacupuncture(transcutaneous electrical acupuncture point stimulation )

Procedure

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

placebo needle

Drug

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

Remimazolam

Drug

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

Primary outcomes

  1. patient satisfaction with sedation instrument，PSSI

    Time frame: During gastroscopy and colonoscopy

    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）.

  2. clinical satisfaction with sedation instrument，CSSI

    Time frame: During gastroscopy and colonoscopy

    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）.

  3. patient's pain score

    Time frame: During gastroscopy and colonoscopy

    The investigator 2 needs to use VAS scores to evaluate patients' pain score .The score from 0 （extremely dissatisfied）to 10（extremely satisfied）.

Secondary outcomes

  1. the extent of cardia exposure

    Time frame: During gastroscopy and colonoscopy

    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%）

  2. adverse reactions

    Time frame: During gastroscopy and colonoscopy

    The investigator 2 needs to record the adverse reactions such as nausea、emesis, salivation, restlessness, and breath holding to analyze efficacy of relate treatment.

  3. patient's recovery time

    Time frame: The end of gastroscopy and colonoscopy

    The investigator 2 needs to record to evaluate patient's recovery quality about patients

  4. patient's departure time

    Time frame: The end of gastroscopy and colonoscopy

    The investigator 2 needs to record patient's departure time to evaluate recovery quality about patients

  5. time to resume normal operation

    Time frame: The end of gastroscopy and colonoscopy

    The investigator 2 needs to record the time to resume normal operation about patient

  6. operation time about gastrointestinal endoscopy

    Time frame: During gastroscopy and colonoscopy

    The investigator 2 needs to record operation time about gastrointestinal endoscopy.

  7. heart rate

    Time frame: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy

    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）

  8. pulse oximetry

    Time frame: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy

    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%）

  9. systolic pressure 、diastolic pressure

    Time frame: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy

    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）

  10. respiratory rate

    Time frame: before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy

    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）

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2022
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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