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Completed

NCT Number: NCT04656964

Comparison Between Remimazolam Tosilate and Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy

Midazolam is a commonly used drug in gastrointestinal endoscopy due to the good cardiovascular stability and mild respiratory depression for elderly patients. However, there is the concern about the the longer and less predictable recovery or the potential for repeat sedation when the active metabolite becomes bioavailable. Remimazolam Tosilate is an innovative benzodiazepine with better sedation effect and less recovery or resedation issues than midazolam, which possibly make the drug more suitable in elderly patients. We aim to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.

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Key information

Conditions

Elderly Patients Gastrointestinal Endoscopy Midazolam Remimazolam

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100049, China

About this study

Before starting the endoscopy procedures, patients were randomized to receive remimazolam tosilate or midazolam to maintain sufficient sedation, then remifentanil was slowly injected for patients' sufficient analgesia during the examination. We aim to use patients' recovery time, cognition function and other measurement scales to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Scheduled to undergo a routine diagnostic or therapeutic gastrointestinal endoscopy ;
  • Age 60 to 75 ;
  • ASA physical status score of I, II or III;
  • A body mass index (BMI) of 19 to 28 kg/m2;
  • Systolic blood pressure of 90-140mmHg, diastolic blood pressure of 50-90mmHg, resting heart rate of 50-100bpm and blood pulse oxygen saturation ≥95%

Exclusion criteria

  • Those who are refused to be included;
  • Those who are allergic to the drugs used in this study;
  • Epilepsy and other mental illnesses, a history of addiction such as opiates and other analgesics and/or tranquilizers (hypnotics);
  • Severe cardiac dysfunction: NYHA cardiac functions grade 3-4, a history of recent myocardial infarction or cerebral infarction, severe conduction block or malignant arrhythmia;
  • Renal failure or liver cirrhosis;
  • Severe lung infection or upper respiratory tract infection;
  • Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status;
  • Advanced cancer accompanied by extensive intra-abdominal metastasis, acute and chronic obstruction of the gastrointestinal tract, bleeding and severe abdominal effusion;

Treatment and study plan

remimazolam tosilate group

Drug

Patients received an initial dose of 0.2mg/kg of remimazolam tosilate(plus repeated 2.5 mg top-ups doses to a total of up to 12.5mg within 15 minutes).

Midazolam Group

Drug

Patients received an initial dose of 0.03mg/kg of midazolam(One additional dose of 0.015 mg / kg midazolam was allowed).

Primary outcomes

  1. Recovery time after operation

    Time frame: Day 0

    First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug.

Secondary outcomes

  1. Supine heart rate[HR]

    Time frame: Day 0

    Supine heart rate[HR] in (times)

  2. Modified Observer's Assessment of Alertness/Sedation[MOAA/S]

    Time frame: Day 0

    MOAA/S score ranges from 0 to 5 points, 0 point means patients do not respond to noxious stimulation; 5 point means patients responds readily to name spoken in normal tone. When the Modified Observer's Assessment of Alertness/Sedation [MOAA/S] ≤4 that patients are sufficiently sedated.

  3. Visual analogue scale (VAS)

    Time frame: Day 0

    The visual analogue scale (VAS) score ranges from 0 to 10 points (0mm means patients feel no pain, 100mm means patients feel the most severe pain imaginable)

  4. Post-anesthesia discharge score (PADS)

    Time frame: Record within 2 hours ，no more than 6 hours

    Post-anesthesia discharge score PADS score ranges from 0 to 10 points. only when the PADS score≥9 that will the patients leave the post-anesthesia care unit(PACU).

  5. Perioperative anesthesia effect

    Time frame: Day 0

    Induction time（from the drug administration to the start of endoscopy insertion); procedure time(from the endoscopy insertion to the end of procedure);PACU last time(from the entry to PACU to the PADS score≥9).

  6. Drug dosages

    Time frame: Day 0

    The total single dosage of midazolam, propofol, remifentanil and remimazolam tosilate.

  7. Simple Intelligence Assessment Scale (mini-cog)

    Time frame: Every 4 hours, up to 1 week.

    • Ask the subjects to listen carefully and memorize 3 unrelated words, and then repeat (Apple, Watch, Coin);
    • Ask the subjects to draw the shape of the clock on a blank sheet of paper, and give the subject a time to mark it on the clock (the CDT of the clock drawing test is correct; it can correctly indicate the sequence of the digits and display the given Fixed time);
    • Ask the subject to say the 3 words given previously.

  8. Patient overall satisfaction and surgeon satisfaction score

    Time frame: Day 0

    The patient's overall satisfaction score and surgeon satisfaction score were evaluated by 1-10 points (1mm=completely dissatisfied, 100mm=completely satisfied).

  9. Systolic, diastolic, and mean blood pressure [MBP]

    Time frame: Day 0

    Systolic, diastolic, and mean blood pressure [MBP] in(mmHg)

  10. Assessment of pulse oximetry measurements[SpO2]

    Time frame: Day 0

    Assessment of pulse oximetry measurements[SpO2]in(%)

  11. Respiration rate[RR]

    Time frame: Day 0

    Respiration rate[RR] in (times)

  12. End-tidal carbon dioxide [EtCO2]

    Time frame: Day 0

    End-tidal carbon dioxide [EtCO2] in (%)

  13. Rate of coughing and vomiting

    Time frame: Within 24 hours

    Rate of coughing and vomiting in（%）

  14. Level of hypoxia

    Time frame: Within 24 hours

    Oxygen saturation <90% for more than 1 minute ，that share a common Unit of Measure in（%）

  15. Respiratory depression

    Time frame: Within 24 hours

    Respiratory rate < 8 breaths per minute ,that share a common Unit of Measure in（times）

  16. Abdominal pain and nausea

    Time frame: Within 24 hours

    Abdominal pain and nausea in （%）

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Emergency General Hospital
  • Fenyang Hospital Affiliated to Shanxi Medical University

Registry information

Official study title

The Safety and Effectiveness of Remimazolam Tosilate Versus Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy: A Multicenter ,Prospective, Double-Blinded, Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 7, 2020
Registry last updated
Jun 22, 2023

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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