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

NCT05103696 | Completed

• 1 other identifier: 2021PHB002-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Patients; Gastrointestinal Endoscopy; Remimazolam Besylate; Etomidate Combined With Propofol

Keywords

Remimazolam Besylate; Etomidate combined with propofol; Gastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (4)

• 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

• Recovery time

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

  day 0

• 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

• Observation time in the PACU

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

  day 0

Secondary Outcomes (12)

• Simple Intelligence Assessment Scale (mini-cog)

  Every 4 hours, up to 1 week

• Drug dosages

  day 0

• Patient overall satisfaction and surgeon satisfaction score

  day 0

• Visual analogue scale (VAS)

  day 0

• Level of hypoxia

  day 0

Study Arms (2)

Remimazolam group

EXPERIMENTAL

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

EP group

ACTIVE COMPARATOR

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

Interventions

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

Remimazolam group

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

EP group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100049, China

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Anesthesiology department

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 30, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)