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

Elderly Patients Clinical Trial

Official title:

Safety and Efficacy of Remazolam in Gastroenteroscopy in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05103696
• Other study ID #: 2021PHB002-001
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: July 2023
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 30, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Elderly Patients
• Gastrointestinal Endoscopy

Intervention

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
• 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

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Recovery time	First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug	day 0
Primary	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
Primary	Observation time in the PACU	the time interval between "endoscope removal" and "departure from the recovery room" (PADS score=9)	day 0
Secondary	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
Secondary	Drug dosages	The total single dosage of remimazolam , propofol, etomidate,remifentanil and tosilate.	day 0
Secondary	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
Secondary	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
Secondary	Level of hypoxia	Oxygen saturation <90% for more than 1 minute #that share a common Unit of Measure in(%)	day 0
Secondary	Respiratory depression	Respiratory rate < 8 breaths per minute ,that share a common Unit of Measure in(times)	day 0
Secondary	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
Secondary	Supine heart rate[HR]	Supine heart rate[HR] in (times)	day 0
Secondary	Systolic, diastolic, blood pressure	Systolic, diastolic, blood pressure in(mmHg)	day 0
Secondary	Assessment of pulse oximetry measurements[SpO2]	Assessment of pulse oximetry measurements[SpO2]in(%)	day 0
Secondary	Respiration rate[RR]	Respiration rate[RR] in (times)	day 0
Secondary	End-tidal carbon dioxide [EtCO2]	End-tidal carbon dioxide [EtCO2] in (%)	day 0