REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry

Phase 4

Recruiting

• Conditions: Anesthesia; Surgery-Complications
• Interventions: Drug: Remimazolam; Drug: Propofol

• Registration Number: NCT05728775
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Status Verified: 2023-04
• Study Start: 2023-04-03
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07
• Primary Completion: 2024-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7188

Inclusion 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:

  1. history of coronary artery disease;
  2. history of stroke;
  3. history of congestive heart failure;
  4. preoperative NT-proBNP >200 pg/mL or BNP>92 pg/mL;
  5. age ≥70 years;
  6. diabetes requiring medical treatment;
  7. ASA status 3 or 4;
  8. history of chronic kidney disease (preoperative sCr >133 μmol/L or 1.5 mg/dL);
  9. history of peripheral arterial disease;
  10. preoperative serum albumin <30 g/L;
  11. preoperative hemoglobin <100 g/L.

Exclusion Criteria

• Undergoing organ transplantation, cardiac, craniocerebral, burn or interventional 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 interventional study;
• Previous participation in this study;
• Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam TIVA	Remimazolam	Remimazolam is administered at 6-12 mg/kg/h intravenously for anesthesia induction and at 1.0-2.0 mg/kg/h for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.
Propofol TIVA	Propofol	Propofol 1.5-2.5mg/kg is administered intravenously for anesthesia induction and propofol at 4-12mg/kg/h is used for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.

Primary Outcome Measures

Name	Time	Method
Days alive and out of hospital at day 30	30 days after randomization	Number of days alive and out of hospital

Secondary Outcome Measures

Name	Time	Method
All-cause 30-day mortality	30 days after randomization	Number of patients who die of any cause
Postoperative complications	30 days after randomization	Number of patients who experience postoperative complications
Quality of Recovery-15 score on the first day after surgery	Postoperative day 1	Using Quality of Recovery-15 questionnaire to evaluate the quality of perioperative recovery. Quality of Recovery-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score is the Quality of Recovery-15 score of the patient.
Length of hospital stay	30 days after randomization	Number of days in hospital
Unplanned re-hospitalization	30 days after randomization	Number of patients who experience unplanned hospital re-admissions

Trial Locations

Locations (17)

Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Southern Medical University Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

The Affiliated Hospital of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Wuhan University People's Hospital; 🇨🇳 Wuhan, Hubei, China

The First Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Xinqiao Hospital of Chongqing; 🇨🇳 Chongqing, Chongqing, China

The Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The First People's Hospital of Yunnan Province; 🇨🇳 Kunming, Yunnan, China

Jiangsu Provincial People's Hospital; 🇨🇳 Nanjing, Jiangsu, China

General Hospital of Northern Theater Command; 🇨🇳 Shenyang, Liaoning, China

Southern Medical University Zhujiang Hospital; 🇨🇳 Guangzhou, Guangdong, China

The Second Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Hunan Provincial People's Hospital; 🇨🇳 Changsha, Hunan, China

The First Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China