Clinical trial NCT05429086: Explore the Advantages of Remimazolam Used on Gastroscopy
Official title: Explore the Advantages of Remimazolam Used on Gastroscopy : A Large Sample, Multicenter, Randomized, Double-blind, Parallel-controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Induction of Anesthesia
Keywords: remimazolam
propofol
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There are many different types of intravenous anesthetics used in gastroscopy, but each type of drug has its advantages and disadvantages,remimazolam is a novel ultra-short-acting benzodiazepine with rapid onset and recovery, low circulatory depression, and rapid reversal of sedation by flumazenil,remimazolam may be another relatively ideal sedative-hypnotic option for anesthesiologists and gastrointestinal endoscopists. The purpose of this study was to explore whether remimazolam combined with propofol is safer and more effective than remimazolam alone or propofol alone in gastrointestinal endoscopy.

Detailed description: Sedation for gastroscopy is still a topic of debate in the global anesthesia and gastroenterology communities, and the sedation protocols of anesthesiologists and endoscopists vary widely. There are many different types of intravenous anesthetic drugs used in gastroscopy, but each type of drug has its advantages and disadvantages, and the most common protocol in anesthesia practice is an opioid (e.g., fentanyl) combined with a sedative-hypnotic drug (e.g., propofol and midazolam). But these protocols usually have limitations with propofol mainly focusing on respiratory depression and circulatory depression, in which perioperative hypotension should be considered a serious public health problem and should be taken seriously by clinicians, while midazolam has a long onset of action and a long recovery time. Therefore, there is an urgent clinical need for a fast-onset, fast-recovery drug with a high safety profile to solve this current dilemma.

As a new ultra-short-acting benzodiazepine with rapid onset and recovery, low circulatory depression, and rapid reversal of sedation by flumazenil, remimazolam may be another relatively ideal sedative-hypnotic option for anesthesiologists and gastrointestinal endoscopists. The drug was approved for procedural sedation in 2020, and there are many studies on the use of remimazolam versus propofol in gastrointestinal endoscopy sedation. A non-inferiority clinical study of remimazolam tosilate in the upper gastrointestinal tract showed that remimazolam had a sedation success rate no lower than that of propofol, a longer onset of sedation than propofol, but a shorter time to full consciousness than propofol, and a significantly lower incidence of adverse events than propofol. These findings suggest that remimazolam is indeed safer than propofol, but its depth of sedation may be inferior to that of propofol. For clinical workers, it is also essential to have good depth of sedation while ensuring safety. Therefore, considering the above, we hypothesized that the use of remimazolam in combination with propofol in gastrointestinal endoscopy could meet clinical sedation needs and also reduce the incidence of respiratory depression and circulatory depression, which have not been reported. The purpose of this study was to determine whether remimazolam combined with propofol is safer and more effective than remimazolam alone or propofol alone in gastrointestinal endoscopy.

Eligibility criteria: Inclusion Criteria:

1. Patients who are to undergo painless gastroscopy
2. Patients aged 18 - 80 years, regardless of gender
3. 18 \< BMI \< 30 kg/m2.
4. American Society of Anesthesiologists (ASA) classification of I-III.

Exclusion Criteria:

1. Preoperative hypertensive patients \>180/110 mm Hg or hypotensive patients \<80/50 mm Hg.
2. Heart rate \<50 beats/min.
3. A history of acute inflammation of the respiratory tract that has not been cured within 2 weeks; severe metabolic diseases of the heart, brain, lungs, liver, kidneys and diabetes mellitus; previous heart attack, severe myocardial, ischemia, severe atrioventricular block
4. Those who may have or have had a difficult airway or a history of recovery from abnormal surgical anesthesia
5. Patients with significant electrolyte disturbances such as hyperkalemia
6. Patients with a history of long-term use of immunosuppressive agents such as hormones or adrenal cortical suppression
7. Patients with known allergy to emulsions and opioids
8. Those with combined use of other sedative and analgesic drugs within the preoperative period (including injections, oral and use of related proprietary Chinese medicines)
9. Those suspected of abusing narcotic analgesics or sedatives
10. Those who have neuromuscular system diseases, mental diseases, etc. who do not cooperate and cannot communicate.

Primary outcomes:
measure: Incidence of hypotension
timeFrame: Day 1
Secondary outcomes:
measure: Sedation success time
timeFrame: Day 1
measure: Injection pain
timeFrame: Day 1
measure: Orientational force score
timeFrame: Day 1
measure: Ataxia Scale
timeFrame: Day 1
Other outcomes:
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Study officials:
References: