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

Safety and Efficacy of Remazolam 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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Endoscopy; Elderly Patients; Remimazolam Besylate; Etomidate Combined With Propofol
• Intervention / Treatment: Drug: etomidate combined with propofol; Drug: Remimazolam Besylate

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhang Qin, Deputy Chief Physician; Phone Number: 18500371299; Email: 819893641@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100049
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with asAI-II indications for painless gastroenteroscopy and receiving diagnostic or therapeutic gastroenteroscopy;
2. 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:

1. Those who are refused to be included;
2. Those who are allergic to the drugs used in this study;
3. Epilepsy and other mental illnesses, a history of addiction such as opiates and other analgesics and/or tranquilizers (hypnotics);
4. Severe lung infection or upper respiratory tract infection;

7. Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status; 8. Advanced cancer accompanied by extensive intra-abdominal metastasis;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam group; Patients received remimazolam to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were injected remifentanil 0.3μg/kg (infusion time > 1min) at the first time，When the analgesia was insufficient, Remifentanil can be added according to the situation.	Drug: Remimazolam Besylate; 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
Active Comparator: EP group; Patients received Etomidate combined with propofol to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were injected remifentanil 0.3μg/kg (infusion time > 1min) at the first time.When the analgesia was insufficient,Remifentanil can be added according to the situation	Drug: etomidate combined with propofol; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Observer's Assessment of Alertness/Sedation[MOAA/S]	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.	day 0
Recovery time	First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug	day 0
induction time	The time from the beginning of the drug injection to the time when the patient does not respond to the verbal call	day 0
Observation time in the PACU	the time interval between "endoscope removal" and "departure from the recovery room" （PADS score≥9）	day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supine heart rate[HR]	Supine heart rate[HR] in (times)	day 0
Assessment of pulse oximetry measurements[SpO2]	Assessment of pulse oximetry measurements[SpO2]in(%)	day 0
Respiration rate[RR]	Respiration rate[RR] in (times)	day 0
End-tidal carbon dioxide [EtCO2]	End-tidal carbon dioxide [EtCO2] in (%）	day 0
Simple Intelligence Assessment Scale (mini-cog)	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.	Every 4 hours, up to 1 week
Drug dosages	The total single dosage of remimazolam , propofol, etomidate，remifentanil and tosilate.	day 0
Patient overall satisfaction and surgeon satisfaction score	The patient's overall satisfaction score and surgeon satisfaction score were evaluated by 1-10 points (1mm=completely dissatisfied, 100mm=completely satisfied).	day 0
Visual analogue scale (VAS)	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)	day 0
Level of hypoxia	Oxygen saturation <90% for more than 1 minute #that share a common Unit of Measure in（%）	day 0
Respiratory depression	Respiratory rate < 8 breaths per minute ,that share a common Unit of Measure in（times）	day 0
Rate of nause、vomiting、 dizziness、hiccups、 cough choking 、body movement	Rate of nause、vomiting、 dizziness、hiccups、 cough choking 、body movement in （%） Rate of coughing and vomiting in（%）	Within 24 hours
Systolic, diastolic, blood pressure	Systolic, diastolic, blood pressure in(mmHg)	day 0

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Gastrointestinal Endoscopy; Remimazolam Besylate; Etomidate combined with propofol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol; Etomidate
• Other Study ID Numbers: 2021PHB002-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No