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Compares treatment options for Anesthesia
Official title REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry
ClinicalTrials.gov ID: NCT05728775
What this study is testing
What is Remimazolam?
Remimazolam is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anesthesia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this randomized controlled trial is to compare total intravenous anesthesia with remimazolam vs total intravenous anesthesia with propofol in moderate-to-high risk patients undergoing major elective noncardiac surgery under general anesthesia. The primary hypothesis is that total intravenous anesthesia with remimazolam can increase days alive and out of hospital at postoperative day 30 compared with total intravenous anesthesia with propofol.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- Age ≥45 years;
- Undergoing elective major surgery under general anesthesia (expected surgery time \>2 h, expected length of postoperative stay \>2 d);
- Fulfilling ≥1 of the following criteria:
- history of coronary artery disease;
- history of stroke;
You likely can't join if
- Undergoing organ transplantation, cardiac, craniocerebral, burn or treatment operations;
- Low risk or minor surgery
- End-stage renal disease requiring renal-replacement therapy;
- Hepatic dysfunction (Child B or C);
- Previous liver or kidney transplantation;
- Previous allergy to general anesthetics;
See the full eligibility criteria
- Age ≥45 years;
- Undergoing elective major surgery under general anesthesia (expected surgery time \>2 h, expected length of postoperative stay \>2 d);
- Fulfilling ≥1 of the following criteria:
- history of coronary artery disease;
- history of stroke;
- history of congestive heart failure;
- preoperative NT-proBNP \>200 pg/mL or BNP\>92 pg/mL;
- age ≥70 years;
- diabetes requiring medical treatment;
- ASA status 3 or 4;
- history of chronic kidney disease (preoperative sCr \>133 μmol/L or 1.5 mg/dL);
- history of peripheral arterial disease;
- preoperative serum albumin \<30 g/L;
- preoperative hemoglobin \<100 g/L.
- Undergoing organ transplantation, cardiac, craniocerebral, burn or treatment operations;
- Low risk or minor surgery
- End-stage renal disease requiring renal-replacement therapy;
- Hepatic dysfunction (Child B or C);
- Previous liver or kidney transplantation;
- Previous allergy to general anesthetics;
- Unable to receive bispectral index monitoring;
- ASA score ≥5;
- Exposure to general anesthesia in prior 30 days or anticipated re-exposure to general anesthesia within 30 days after surgery;
- Need for prolonged airway protection or mechanical ventilatory support after surgery;
- Current participation in another treatment study;
- Previous participation in this study;
- Pregnant or breastfeeding women.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Huainan, Anhui, China
- Suzhou, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Foshan, Guangdong, China
- Guangzhou, Guangdong, China
- Zhongshan, Guangdong, China
- Guiyang, Guizhou, China
- Kaili, Guizhou, China
- Shijiazhuang, Hebei, China
- Kaifeng, Henan, China
- Pingdingshan, Henan, China
- Shangqiu, Henan, China
- Xuchang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Hengyang, Hunan, China
- Baotou, Inner Mongolia, China
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Huainan, Anhui, China; Suzhou, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Foshan, Guangdong, China and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.