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NCT Number: NCT06376760

Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy

To compare the dosage requirement of intravenous anesthetics during digestive endoscopy between patients with insomnia and those with normal sleep pattern.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Fang Luo, M.D.

CONTACT

[email protected]

13611326978

Fang Luo, M.D.

PRINCIPAL_INVESTIGATOR

About this study

The investigators aim to investigate whether intravenous anesthetic drug dosage requirement is increased in patients with insomnia undergoing digestive endoscopy compared with normal sleep patterns.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with insomnia:
  • Age of 18 - 64 years;
  • ASA physical status of I - II;
  • BMI of 15 - 30;
  • Scheduled for digestive endoscopy under intravenous anesthesia;
  • Positive screening results according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder;
  • 8-item Sleep Condition Indicator (SCI; score 0-4; range 0-32, higher score means better sleep) scored 16 or less;
  • Patients with normal sleep:
  • Age of 18 - 64 years;
  • ASA physical status of I - II;
  • BMI of 15 - 30;
  • Scheduled for digestive endoscopy under intravenous anesthesia;
  • No history or evidence of insomnia.

Exclusion criteria

  • 1. Associated with any neurological disease; 2. Daily alcohol consumption; 3. Any contraindication to intravenous anesthetic drug, such as hypotension or shock; 4. History of allergy to any drug used in the study; 5. Pregnancy or breastfeeding; 6. Patients with sleep apnea syndrome; 7. acute upper respiratory infection; 8. Patients with psychological diseases who report suicidal thoughts; 9. Patients who need to work or take care of children/elderly people frequently at night.

Treatment and study plan

No interventions, it is a observational study

Other

No interventions, this study is to compare the dosage requirement of intravenous anesthetic drug during digestive endoscopy between insomnia group and normal sleep group.

Primary outcomes

  1. The total consumption of intravenous anesthetic drug

    Time frame: Up to 1 day

    The total consumption of intravenous anesthetic drug for digestive endoscopy. It includes the total amount of intravenous anesthesia drugs required by the patient for the entire process of digestive endoscopy.

Secondary outcomes

  1. The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope

    Time frame: 1 day

    The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope

  2. The occurrence of the respiratory and cardiovascular adverse events

    Time frame: The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy

    The occurrence of the respiratory and cardiovascular adverse events such as hypoxemia, hypotension, hypertension, arrhythmia

  3. The occurrence of the other adverse events

    Time frame: The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy

    The occurrence of the other adverse events such as dizziness, agitation, nausea, vomiting and psychiatric symptom

  4. The incidence of intraoperative recall or awareness

    Time frame: The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy

    The patient is conscious after anesthesia

  5. The recovery time

    Time frame: Up to 1 day

    The time from when the patient stops intravenous anesthetic drug application to when they can open their eyes and nod their heads.

  6. Duration of patients' PACU stay

    Time frame: Up to 1 day

    Patients' stay time in PACU

  7. The ease of operation at this level of sedation evaluated by the gastroenterologists

    Time frame: Up to 1 day

    The ease of operation at this level of sedation (easy/medium/difficult) evaluated by the gastroenterologists

  8. The satisfaction degree of anesthesia effect evaluated by the gastroenterologists

    Time frame: Up to 1 day

    The satisfaction degree of anesthesia effect (satisfactory/medium/unsatisfactory) evaluated by the gastroenterologists

  9. Patients' satisfaction

    Time frame: Up to 1 day

    Patients' satisfaction with the procedure at this level of sedation (satisfactory/medium/unsatisfactory)

  10. Patients' willingness

    Time frame: Up to 1 day

    Patients' willingness to undergo the next procedure at the same level of sedation

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Daxing Teaching Hospital, Capital Medical University
  • Hebei Medical University Third Hospital
  • Hengshui People's Hospital

Registry information

Official study title

Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy: Study Protocol for a Prospective Cohort Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2024
Registry last updated
Sep 10, 2025

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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