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

NCT05437497 | Unknown

• 1 other identifier: EUS-FNA-2022-01
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Ultrasonography-guided Fine Needle Aspiration; Sedation Complication; Remimazolam

Keywords

Endoscopic ultrasound-guided fine needle aspiration; Sedation Complication; remimazolam

Outcome Measures

Primary Outcomes (1)

• Cardiopulmonary adverse event incidence

  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

  The whole EUS-FNA/FNB procedure

Secondary Outcomes (2)

• Adverse event incidence

  The whole EUS-FNA/FNB procedure

• Sedation success rate:

  The whole EUS-FNA/FNB procedure

Other Outcomes (1)

• Dosage of sedations

  The whole EUS-FNA/FNB procedure

Study Arms (2)

Remimazolam group

EXPERIMENTAL

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

Propofol group

ACTIVE COMPARATOR

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

Interventions

Remimazolam Injection DRUG

The experimental group was sedated with remimazolam

Remimazolam group

Propofol Injection DRUG

The control group was sedated with propofol

Propofol group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Patients who are not suitable for sedated EUS-FNA/FNB for any reason (e.g. cardiovascular disease)
• Patients have abnormal liver function, AST and/or ALT≥2.5×ULN, TBIL≥1.5×ULN;
• Patients have abnormal renal function, urea or blood urea nitrogen≥1.5×ULN, serum creatinine≥1.0 ×ULN
• Those who are allergic to benzodiazepines, opioids, propofol or lidocaine.
• Patients have contraindications for benzodiazepines, opioids, propofol or lidocaine.
• Patients have benzodiazepines, opioids, propofol, lidocaine suspected narcotic drug abuse history and pain drug or sedative abuse.
• 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)

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

Related Publications (18)

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MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

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

Study Officials

• Xiaoyan Wang, Doctor

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Wang, Doctor

CONTACT

+8673188618011; 912877437@qq.com

Ning Fang, Doctor

CONTACT

+8618160992303; golempowers@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Care provider(anesthesiologist) cannot be blinded for different appearance of propofol and remimazolam.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: The experimental group was sedated with remimazolam, and the control group was sedated with propofol;

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: August 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)