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Safety and Efficacy Evaluation of Remimazolam for Endoscopic Ultrasound-guided Fine Needle Aspiration/Biopsy

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ClinicalTrials.gov Identifier: NCT05437497
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : June 29, 2022
Sponsor:
Information provided by (Responsible Party):
wang xiaoyan, The Third Xiangya Hospital of Central South University

Brief Summary:
This study aims to compare the safety and efficacy of remimazolam and propofol in EUS-FNA/FNB sedation. This study is a prospective, single-blind study. We plan to enroll 264 patients undergoing EUS-FNA and divide them into two groups. The experimental group was sedated with remimazolam, and the control group was sedated with propofol; safety and efficacy parameters such as intraoperative blood pressure, finger pulse oxygen, heart rate and sedation success rate would be compared. We hypothesized that patients in the experimental group would be superior in terms of safety parameters; the two would be equal in terms of sedation success.

Condition or disease Intervention/treatment Phase
Endoscopic Ultrasonography-guided Fine Needle Aspiration Sedation Complication Remimazolam Drug: Remimazolam Injection Drug: Propofol Injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The experimental group was sedated with remimazolam, and the control group was sedated with propofol;
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Care provider(anesthesiologist) cannot be blinded for different appearance of propofol and remimazolam.
Primary Purpose: Supportive Care
Official Title: Safety and Efficacy Evaluation of Remimazolam for Endoscopic Ultrasound-guided Fine Needle Aspiration/Biopsy
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Endoscopy
Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: Remimazolam group
  1. Background oxycodone injection: Slowly inject oxycodone(0.05mg/kg) intravenously. Three minutes (± 1min) after the end of oxycodone injection , begin sedation induction as follows.
  2. Sedation induction before EUS-FNA/FNB: the initial dose of remimazolam is 0.15-0.2 mg/kg, and the intravenous injection time is about 1 minute. If the subject's MOAA/S score is 1 point or below after the initial dose, EUS-FNA/FNB can be started; if the degree of sedation is insufficient, additional remimazolam(0.05 mg/kg each time) is allowed. The injection time of additional remimazolam is not less than 15 seconds, and the time interval between each additional administration is ≥ 2 minutes.
  3. Maintenance of sedation: In order to maintain the MOAA/S≤1, the investigator can decide to add remimazolam 0.05mg/kg each time, and the intravenous injection time should not be less than 15 seconds, with an additional administration interval of ≥ 2 minutes.
Drug: Remimazolam Injection
The experimental group was sedated with remimazolam

Active Comparator: Propofol group
  1. Background oxycodone injection: Slowly inject oxycodone(0.05mg/kg) intravenously. Three minutes (± 1min) after the end of oxycodone injection , begin sedation induction as follows.
  2. Sedation induction before EUS-FNA/FNB: the initial dose of propofol is 1.5-2.0 mg/kg, and the intravenous injection time is about 1 minute. If the subject's MOAA/S score is 1 point or below after the initial dose, EUS-FNA/FNB can be started; if the degree of sedation is insufficient, additional propofol(0.5 mg/kg each time) is allowed. The injection time of additional propofol is not less than 15 seconds, and the time interval between each additional administration is ≥ 2 minutes.
  3. Maintenance of sedation: In order to maintain the MOAA/S≤1, the investigator can decide to add propofol 0.5mg/kg each time, and the intravenous injection time should not be less than 15 seconds, with an additional administration interval of ≥ 2 minutes.
Drug: Propofol Injection
The control group was sedated with propofol




Primary Outcome Measures :
  1. Cardiopulmonary adverse event incidence [ Time Frame: The whole EUS-FNA/FNB procedure ]
    The occurrence of any one of the following reactions was recorded as "Cardiopulmonary Adverse Event", and the cardiopulmonary adverse event incidence was defined as the proportion of the subjects with cardiopulmonary adverse events in each group. Cardiopulmonary adverse events were defined as: any of the following conditions occurred during the operation: 1. respiratory depression: oxygen saturation <90%, or breathing <8 times/min; 2. apnea: respiratory airflow stopped for more than 15s; 3. hypotension: systolic blood pressure decrease greater than 20% of baseline systolic blood pressure; 4. hypertension: systolic blood pressure increase greater than 20% of baseline systolic blood pressure; 5. tachycardia: heart rate>100bpm for 1 minute or more; 6. bradycardia: HR<50, lasting 1 minute or more


Secondary Outcome Measures :
  1. Adverse event incidence [ Time Frame: The whole EUS-FNA/FNB procedure ]
    The respective incidence of each adverse event that occurred during the EUS-FNA/FNB procedure, such as the incidence of cough or body movement.

  2. Sedation success rate: [ Time Frame: The whole EUS-FNA/FNB procedure ]
    Sedation success was defined as: completion of the entire procedure; no sedative rescue medication administered; ≤5 additional doses in any 15-minute period from the end of the initial dose of the trial drug. The sedation success rate was defined as the proportion of subjects in the group who were successfully sedated.


Other Outcome Measures:
  1. Dosage of sedations [ Time Frame: The whole EUS-FNA/FNB procedure ]
    The total dosage of remimazolam or propofol and the dosage per kilogram of body weight.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: ≥18 years old and ≤75 years old
  2. BMI: 18kg/m^2<BMI<30kg/m^2;
  3. Body weight: 40kg<weight<120kg
  4. Patients who intend and qualified to undergo sedated EUS-FNA/FNB.
  5. Clearly understand, voluntarily participate in the research, and sign the informed consent form.

Exclusion Criteria:

  1. Patients who are not suitable for sedated EUS-FNA/FNB for any reason (e.g. cardiovascular disease)
  2. Patients have abnormal liver function, AST and/or ALT≥2.5×ULN, TBIL≥1.5×ULN;
  3. Patients have abnormal renal function, urea or blood urea nitrogen≥1.5×ULN, serum creatinine≥1.0 ×ULN
  4. Those who are allergic to benzodiazepines, opioids, propofol or lidocaine.
  5. Patients have contraindications for benzodiazepines, opioids, propofol or lidocaine.
  6. Patients have benzodiazepines, opioids, propofol, lidocaine suspected narcotic drug abuse history and pain drug or sedative abuse.
  7. Patients have history of drug use and/or alcoholism within 2 years before the start of the period. Alcoholism means drinking more than 2 units of alcohol on average per day (1 unit = 360 mL of beer or 45 mL of liquor with an alcohol content of 40% or 150 mL of wine)

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): NCT05437497


Contacts
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Contact: Xiaoyan Wang, Doctor +8673188618011 912877437@qq.com
Contact: Ning Fang, Doctor +8618160992303 golempowers@csu.edu.cn

Locations
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China, Hunan
The Third Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410013
Contact: Xiaoyan Wang, Doctor    +8673188618011    912877437@qq.com   
Contact: Ning Fang, Doctor    +8618160992303    golempowers@csu.edu.cn   
Sponsors and Collaborators
The Third Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Xiaoyan Wang, Doctor The Third Xiangya Hospital of Central South University
  Study Documents (Full-Text)

Documents provided by wang xiaoyan, The Third Xiangya Hospital of Central South University:
Study Protocol  [PDF] May 10, 2022
Statistical Analysis Plan  [PDF] May 10, 2022
Informed Consent Form  [PDF] May 10, 2022

Publications:
Behrens A, Kreuzmayr A, Manner H, Koop H, Lorenz A, Schaefer C, Plauth M, Jetschmann JU, von Tirpitz C, Ewald M, Sackmann M, Renner W, Krüger M, Schwab D, Hoffmann W, Engelke O, Pech O, Kullmann F, Pampuch S, Lenfers B, Weickert U, Schilling D, Boehm S, Beckebaum S, Cicinnati V, Erckenbrecht JF, Dumoulin FL, Benz C, Rabenstein T, Haltern G, Balsliemke M, de Mas C, Kleber G, Pehl C, Vogt C, Kiesslich R, Fischbach W, Koop I, Kuehne J, Breidert M, Sass NL, May A, Friedrich C, Veitt R, Porschen R, Ellrichmann M, Arlt A, Schmitt W, Dollhopf M, Schmidbaur W, Dignass A, Schmitz V, Labenz J, Kaiser G, Krannich A, Barteska N, Ell C. Acute sedation-associated complications in GI endoscopy (ProSed 2 Study): results from the prospective multicentre electronic registry of sedation-associated complications. Gut. 2019 Mar;68(3):445-452. doi: 10.1136/gutjnl-2015-311037. Epub 2018 Jan 3.

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Responsible Party: wang xiaoyan, Doctor, The Third Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT05437497    
Other Study ID Numbers: EUS-FNA-2022-01
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.

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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 wang xiaoyan, The Third Xiangya Hospital of Central South University:
Endoscopic ultrasound-guided fine needle aspiration
Sedation Complication
remimazolam
Additional relevant MeSH terms:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics