Explore the Advantages of Remimazolam Used on Gastroscopy

NCT05429086 | Unknown Phase 4 DMC

• 1 other identifier: HR7056-IIT
• Study Type: interventional
• Target: 287
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Induction of Anesthesia

Keywords

remimazolam; propofol

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension

  20% lower blood pressure than before the drug was administered

  Day 1

Secondary Outcomes (4)

• Sedation success time

  Day 1

• Injection pain

  Day 1

• Orientational force score

  Day 1

• Ataxia Scale

  Day 1

Study Arms (3)

group remimazolam

ACTIVE COMPARATOR

The initial dose of remimazolam was 0.2mg/kg, and the intravenous infusion time was 30s. Within 1 minute (inclusive) of the end of the initial dose: if the subject has achieved sufficient sedation (MOAA/S score ≤3), the gastroscopy will begin; If MOAA/S score \> 3 point, additional administration of remimazoalm will be allowed 1 minute after the end of the initial dose. If the MOAA/S score was \>3 after 3 consecutive times of addition, sedation failure was determined, and the study was recorded and quit. The drug was given according to clinical needs and the examination was completed. Maintenance of sedation after gastroscopy: In order to maintain a certain degree of sedation after gastroscopy , the evaluator decides when to administer additional drugs. remimazolam supplemental administration: the supplemental dose was 2.5 mg , bolus

Drug: Remimazolam

group propofol

ACTIVE COMPARATOR

The initial dose of propofol was 2mg/kg, and the intravenous infusion time was 30s. Within 1 minute (inclusive) of the end of the initial dose: if the subject has achieved sufficient sedation (MOAA/S score ≤3), the gastroscopy will commence. If subjects' MOAA/S score \> 3 point, additional administration of propofol will be allowed 1 minute after the end of the initial dose. If the MOAA/S score was \>3 after 3 consecutive times of addition, sedation failure was determined, and the study was recorded and quit. The drug was given according to clinical needs and the examination was completed. Maintenance of sedation after gastroscopy: In order to maintain a certain degree of sedation after gastroscopy , the evaluator decides when to administer additional drugs. Propofol supplemental administration: the supplemental dose was 0.5mg/kg, bolus.

Drug: Propofol

group remimazolam combined propofol

EXPERIMENTAL

The initial dose of remimazolam was 0.1 mg/kg, combined propofol 0.5mg/kg, and the infusion time was 30s. Within 1 minute (inclusive) of the end of the initial dose: if the subject has achieved sufficient sedation (MOAA/S score ≤3), the gastroscopy will begin. If subjects' MOAA/S score \> 3, additional administration of propofol will be allowed. If the MOAA/S score was \>3 after 3 consecutive times of addition, sedation was failure, and the study was recorded and quit. Maintenance of sedation after gastroscopy: In order to maintain a certain degree of sedation after gastroscopy, the evaluator decides when to administer additional drugs. supplemental administration: the supplemental dose was remimazolam 2.5 mg,single dose, bolus. There is no permission to use propofol , unless the MOAA/S score still \> 3 after five consecutive dosing supplement

Drug: Remimazolam combined propofol

Interventions

Remimazolam combined propofol DRUG

Remimazolam combined propofol

group remimazolam combined propofol

Remimazolam DRUG

remimazolam only

group remimazolam

Propofol DRUG

propofol only

group propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Preoperative hypertensive patients \>180/110 mm Hg or hypotensive patients \<80/50 mm Hg.
• Heart rate \<50 beats/min.
• 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
• Those who may have or have had a difficult airway or a history of recovery from abnormal surgical anesthesia
• Patients with significant electrolyte disturbances such as hyperkalemia
• Patients with a history of long-term use of immunosuppressive agents such as hormones or adrenal cortical suppression
• Patients with known allergy to emulsions and opioids
• Those with combined use of other sedative and analgesic drugs within the preoperative period (including injections, oral and use of related proprietary Chinese medicines)
• Those suspected of abusing narcotic analgesics or sedatives
• Those who have neuromuscular system diseases, mental diseases, etc. who do not cooperate and cannot communicate.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Related Publications (1)

• Wei A, Ma S, Dou Y, Wang X, Wu J, Zhou S, Deng Y, Liu X, Li D, Yang M. The safety and efficacy of remimazolam tosylate combined with propofol in upper gastrointestinal endoscopy: A multicenter, randomized clinical trial. PLoS One. 2023 Aug 3;18(8):e0282930. doi: 10.1371/journal.pone.0282930. eCollection 2023.

  PMID: 37535618 DERIVED

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 4, 2022
• First Posted: June 23, 2022
• Study Start: June 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06