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Effect of Remimazolam Use During Perioperative Period on Postoperative Recovery Indicators

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ClinicalTrials.gov Identifier: NCT04601350
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
Zhuan Zhang, Yangzhou University

Study Description
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Brief Summary:
Benzodiazepine sedative hypnotics are commonly used intravenous anesthetics in clinical practice. Remimazolam is a new benzodiazepine with the characteristics of rapid onset, short maintenance and recovery time, no accumulation, metabolism independent of liver and kidney function, and no serious side effects, which has a good prospect for clinical application. Now we will study the emotional response caused by remimazolam during induction of general anesthesia and the postoperative recovery indicators, in order to further understand the clinical application of remimazolam.

Condition or disease Intervention/treatment Phase
Benzodiazepine Drug: Remimazolam with a dose of 0.05mg/kg for induction of general anesthesia Drug: Remimazolam with a dose of 0.1mg/kg for induction of general anesthesia Drug: Remimazolam with a dose of 0.2mg/kg for induction of general anesthesia Drug: Remimazolam with a dose of 0.3mg/kg for induction of general anesthesia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Remimazolam Use During Perioperative Period on Postoperative Recovery Indicators
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : June 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Remimazolam 1 Drug: Remimazolam with a dose of 0.05mg/kg for induction of general anesthesia
Remimazolam with a dose of 0.05mg/kg for induction of general anesthesia
Experimental: Remimazolam 2 Drug: Remimazolam with a dose of 0.1mg/kg for induction of general anesthesia
Remimazolam with a dose of 0.1mg/kg for induction of general anesthesia
Experimental: Remimazolam 3 Drug: Remimazolam with a dose of 0.2mg/kg for induction of general anesthesia
Remimazolam with a dose of 0.2mg/kg for induction of general anesthesia
Experimental: Remimazolam 4 Drug: Remimazolam with a dose of 0.3mg/kg for induction of general anesthesia
Remimazolam with a dose of 0.3mg/kg for induction of general anesthesia


Outcome Measures
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Primary Outcome Measures :
  1. Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure) [ Time Frame: "before surgery", "the time of intubation", the time of extubation", "1min,2min, 3min, 4min, 5min after intubation", "1min,2min, 3min, 4min, 5min after extubation", "one hour after turn into Postanesthesia care unit". ]
    All the outcomes above should be measured at the time before surgery，the above indicators were measured every minute within five minutes after the injection of Remimazolam, the time of intubation, the time of extubation, and every minute within five minutes after extubation, one hour after turn into Postanesthesia care unit.

  2. Changes in the level of Heart Rate [ Time Frame: "before surgery", "the time of intubation", the time of extubation", "1min,2min, 3min, 4min, 5min after intubation", "1min,2min, 3min, 4min, 5min after extubation", "one hour after turn into Postanesthesia care unit". ]
    The outcome above should be measured at the time before surgery，the above indicators were measured every minute within five minutes after the injection of Remimazolam, the time of intubation, the time of extubation, and every minute within five minutes after extubation, one hour after turn into PACU.

  3. Changes in the level of Oxygen saturation [ Time Frame: "before surgery", "the time of intubation", the time of extubation", "1min,2min, 3min, 4min, 5min after intubation", "1min,2min, 3min, 4min, 5min after extubation", "one hour after turn into Postanesthesia care unit". ]
    The outcome above should be measured at the time before surgery，the above indicators were measured every minute within five minutes after the injection of Remimazolam, the time of intubation, the time of extubation, and every minute within five minutes after extubation, one hour after turn into PACU.

  4. Changes in the value and waveform of Narcotrend [ Time Frame: "before surgery", "the time of intubation", the time of extubation", "1min,2min, 3min, 4min, 5min after intubation", "1min,2min, 3min, 4min, 5min after extubation", "one hour after turn into Postanesthesia care unit". ]
    The outcome above should be measured at the time before surgery，the above indicators were measured every minute within five minutes after the injection of Remimazolam, the time of intubation, the time of extubation, and every minute within five minutes after extubation, one hour after turn into PACU.

  5. Changes in the score of Modified Observer's Assessment of Alertness/Sedation [ Time Frame: "before surgery", "the time of intubation", the time of extubation", "1min,2min, 3min, 4min, 5min after intubation", "1min,2min, 3min, 4min, 5min after extubation", "one hour after turn into Postanesthesia care unit". ]

    The outcome above should be measured at the time before surgery，the above indicators were measured every minute within five minutes after the injection of Remimazolam, the time of intubation, the time of extubation, and every minute within five minutes after extubation, one hour after turn into PACU.

    the score of 6 was Agitated the score of 5 was Responds readily to name spoken in normal tone the score of 4 was Lethargic response to name spoken in normal tone the score of 3 was Responds only after name is called loudly and/or repeatedly the score of 2 was Responds only after mild prodding or shaking the score of 1 was Does not respond to mild prodding or shaking the score of 0 was Does not respond to deep stimulus



Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASAⅠ-Ⅱ
  • Patients undergoing elective surgery under general anesthesia.
  • Age, sex, and weight were not limited.

Exclusion Criteria:

  • Allergic or contraindication to remimazolam/midazolam/remifentanil;
  • Abnormal liver and kidney function; Alcohol abuse;
  • Long-term use of sedative, analgesic or anxiolytic drugs;
  • Hearing and language communication disorders;
  • Complicated with severe cardiovascular lesions or neurological diseases.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601350


Contacts
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Contact: Zhuan Zhang, professor +8615062791355 zhangzhuancg@163.com

Locations
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China, Jiangsu
the Affiliated Hospital of Yangzhou University, Yangzhou University Recruiting
Yangzhou, Jiangsu, China
Contact: Zhuan Zhang, professor    +8615062791355 ext +8615062791355    zhangzhuancg@163.com   
Sponsors and Collaborators
Yangzhou University
More Information
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Responsible Party: Zhuan Zhang, Director, Yangzhou University
ClinicalTrials.gov Identifier: NCT04601350    
Other Study ID Numbers: 20200922
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhuan Zhang, Yangzhou University:
remimazolam
recovery
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs