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NCT Number: NCT05103696

A Comparative Study of Rimazolam and Propofol Combined With Etomidate in Gastroenteroscopy in Elderly Patients

Studies have shown that etomidate combined with propofol in gastroscopy has high safety and lower incidence of hypoxia and hypotension, suggesting the advantages of etomidate combined with propofol in elderly patients.

Remimazolam Besylate is a 1.1 class new drug that acts on GABA receptors and is metabolized by plasma esterase with fast metabolism time, only 1/7 of midazolam, which may be more suitable for elderly patients. Therefore, this study intends to explore the safety and effectiveness of two sedation schemes in gastroenteroscopy for elderly patients.

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Key information

Conditions

Elderly Patients Etomidate Combined With Propofol Gastrointestinal Endoscopy Remimazolam Besylate

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 randomly assigned to either Remimazolam Besylate group or propofol combined with etomidate group. The onset time, recovery time, vital signs, postoperative recovery, cognitive function and adverse events were compared.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with asAI-II indications for painless gastroenteroscopy and receiving diagnostic or therapeutic gastroenteroscopy;
  • Aged 60-75, body mass index (BMI) 19-28 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 lung infection or upper respiratory tract infection;
  • Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status; 8. Advanced cancer accompanied by extensive intra-abdominal metastasis;

Treatment and study plan

Remimazolam besylate

Drug

Remazolam 7mg for the first time (push time 1min), 2.5mg can be added after 2min according to MOAA/S score, no more than 5 times within 15min

etomidate combined with propofol

Drug

Etomidate 0.1mg/kg+1% propofol 0.5mg/kg for the first time ,etomidate0.05mg/kg+ 1% propofol 0.25 mg/kg can be added according to MOAA/S score

Primary outcomes

  1. induction time

    Time frame: day 0

    The time from the beginning of the drug injection to the time when the patient does not respond to the verbal call

  2. Recovery time

    Time frame: day 0

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

  3. 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.

  4. Observation time in the PACU

    Time frame: day 0

    the time interval between "endoscope removal" and "departure from the recovery room" （PADS score≥9）

Secondary outcomes

  1. 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.

  2. Drug dosages

    Time frame: day 0

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

  3. 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).

  4. 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)

  5. Level of hypoxia

    Time frame: day 0

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

  6. Respiratory depression

    Time frame: day 0

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

  7. Rate of nause、vomiting、 dizziness、hiccups、 cough choking 、body movement

    Time frame: Within 24 hours

    Rate of nause、vomiting、 dizziness、hiccups、 cough choking 、body movement in （%） Rate of coughing and vomiting in（%）

  8. Supine heart rate[HR]

    Time frame: day 0

    Supine heart rate[HR] in (times)

  9. Systolic, diastolic, blood pressure

    Time frame: day 0

    Systolic, diastolic, blood pressure 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 (%）

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Safety and Efficacy of Remazolam in Gastroenteroscopy in Elderly Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Nov 2, 2021
Registry last updated
Jul 14, 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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