Clinical trial NCT05103696: A Comparative Study of Rimazolam and Propofol Combined With Etomidate in Gastroenteroscopy in Elderly Patients
Official title: Safety and Efficacy of Remazolam in Gastroenteroscopy in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Patients
Gastrointestinal Endoscopy
Remimazolam Besylate
Etomidate Combined With Propofol
Keywords: Remimazolam Besylate
Etomidate combined with propofol
Gastrointestinal Endoscopy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: induction time
timeFrame: day 0
measure: Recovery time
timeFrame: day 0
measure: Modified Observer's Assessment of Alertness/Sedation[MOAA/S]
timeFrame: day 0
measure: Observation time in the PACU
timeFrame: day 0
Secondary outcomes:
measure: Simple Intelligence Assessment Scale (mini-cog)
timeFrame: Every 4 hours, up to 1 week
measure: Drug dosages
timeFrame: day 0
measure: Patient overall satisfaction and surgeon satisfaction score
timeFrame: day 0
measure: Visual analogue scale (VAS)
timeFrame: day 0
measure: Level of hypoxia
timeFrame: day 0
measure: Respiratory depression
timeFrame: day 0
measure: Rate of nause、vomiting、 dizziness、hiccups、 cough choking 、body movement
timeFrame: Within 24 hours
measure: Supine heart rate[HR]
timeFrame: day 0
measure: Systolic, diastolic, blood pressure
timeFrame: day 0
measure: Assessment of pulse oximetry measurements[SpO2]
timeFrame: day 0
measure: Respiration rate[RR]
timeFrame: day 0
measure: End-tidal carbon dioxide [EtCO2]
timeFrame: day 0
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: