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NCT Number: NCT07471893

Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy

This is a prospective clinical study to compare the anesthetic effect of remimazolam combined with remifentanil administered at different time points during gastroscope insertion in patients undergoing painless gastroscopy.The primary outcomes include sedation effect, intraoperative hemodynamic stability, recovery time, and adverse events.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huizhou First People's Hospital

Huizhou, Guangdong, China

About this study

This study hypothesized that a dual criterion (absent jaw reflex and stable heart rate) for guiding endoscope insertion is superior to the single eyelash reflex criterion in painless gastroscopy with remimazolam and remifentanil. A short delay after heart rate stabilization may achieve the best balance of safety and efficacy. This randomized controlled trial aims to verify the dual criterion, determine the optimal insertion time window, and establish a standardized clinical protocol.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA physical status Ⅰ/Ⅱ, BMI 18-24kg/m², scheduled for elective diagnostic painless gastroscopy

Exclusion criteria

  • (1) Allergy to remimazolam, remifentanil, BZDs, or opioids; (2) Difficult airway (Mallampati class Ⅲ/Ⅳ,limited mandibular movement, or restricted neck extension);(3)Severe cardiovascular/cerebrovascular/respiratory/hepatic/renal dysfunction;(4)Pregnancy/lactation;(5)Chronic use of sedatives/analgesics/psychotropic drugs; (6) Preoperative pulmonary infection/respiratory failure; (7) Inability to provide informed consent or complete follow-up.

Treatment and study plan

Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion

Other

Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when jaw reflex is absent and heart rate is stable.

Eyelash reflex guided endoscope insertionn

Other

Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when eyelash reflex is absent.

Primary outcomes

  1. Cough

    Time frame: From start of endoscope insertion until completion of gastroscopy

    Incidence of coughing during endoscope insertion and examination

  2. Body movement

    Time frame: From start of endoscope insertion until completion of gastroscopy

    Incidence of body movement

  3. Hypotension

    Time frame: From start of endoscope insertion until completion of gastroscopy

    Incidence of hypotension

  4. Bradycardia

    Time frame: From start of endoscope insertion until completion of gastroscopy

    Incidence of bradycardia

  5. Hypoxemia

    Time frame: From start of endoscope insertion until completion of gastroscopy

    Incidence of hypoxemia

Secondary outcomes

  1. Endoscopist satisfaction score

    Time frame: Immediately after completion of gastroscopy

    Endoscopist satisfaction score

  2. PACU discharge time

    Time frame: From admission to PACU until discharge from PACU

    Time to discharge from PACU

Sponsors and collaborators

Lead sponsor

Huizhou First Hospital

Other

Registry information

Official study title

Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy: A Single-Center Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

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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