Etomidate to Improve Outcome in Elderly Patients

NCT02910206 | Completed DMC

• 1 other identifier: XJH-A-2015-12-01
• Study Type: interventional
• Target: 1,917
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly patients have high mortality and postoperative complications rate after surgery, especially postoperative cardiac complications. A meta-analysis revealed haemodynamic intraoperative events significantly increased the risk of postoperative cardiac complications.To limit the risk, optimize the intraoperative management of circulation is essential. Anesthetic drug may effect on the haemodynamic intraoperative, reduction of postoperative complications should aimed at choosing the optimal anesthetic drug with minimal effect on haemodynamic.So this study is to explore the comparative efficacy and safety of anesthetic drug (etomidate or propofol) in elderly patients

Conditions

Postoperative Complications

Keywords

etomidate; propofol

Outcome Measures

Primary Outcomes (1)

• Number of participants with complications defined by ICD (International codes of diseases)-9

  From the moment of giving sufentanil to the moment of discharge from hospital,up to 7 days

Secondary Outcomes (16)

• the time to awake from anesthesia

  From stopping etomidate or propofol infusion to awake, approximately 30 minutes

• the time to withdraw tracheal tube from anesthesia

  From end of etomidate or propofol infusion to recovery of spontaneous breathing and withdrawal of tracheal tube,approximately 30 minutes

• the time to discharge from post-anesthesia care unit

  From admit into post-anesthesia care unit to discharge from post-anesthesia care unit,on an average of 30 minutes

• the time to discharge from hospital

  From end of surgery to discharge from hospital,on an average of 7 days

• Post Operative Nausea And vomiting score

  6 hours, 24 hours, 48 hours and 72 hours after end of surgery，approximately 6 hours, 24 hours, 48 hours and 72 hours respectively

Study Arms (2)

etomidate

EXPERIMENTAL

etomidate is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium

Drug: Etomidate; Drug: Sufentanil; Drug: Cisatracurium

propofol

EXPERIMENTAL

propofol is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium

Drug: propofol; Drug: Sufentanil; Drug: Cisatracurium

Interventions

Etomidate DRUG

etomidate is given intravenously

etomidate

propofol DRUG

propofol is given intravenously

propofol

Sufentanil DRUG

sufentanil is given intravenously

etomidate; propofol

Cisatracurium DRUG

Cisatracurium is given intravenously

etomidate; propofol

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged between 65 and 80 years old.
• Patients scheduled for elective gastrointestinal surgery under general anesthesia.

You may not qualify if:

• Expected duration of surgery \< 1 or \>4 hours
• American Society of Anesthesiologists status \>III
• Body Mass Index \< 18 kg/m2 or\> 25 kg/m2
• Cerebrovascular accident occurred within the previous 3 months,such as stroke or transient ischemic attack
• Unstable angina and myocardial infarction occurred within the previous 3 months
• Patients with serious hepatic dysfunction ( the serum level of alanine transaminase, conjugated bilirubin, aspartate transaminase, alkaline phosphatase or total bilirubin is 2 folds more than upper normal limit) or renal dysfunction(creatinine clearance rate less than 30 milliliter per minute).
• Diabetic patients with complication (diabetic ketoacidosis, hyperosmotic coma,all kinds of infection, macroangiopathy, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot).
• Preoperative blood pressure more than or equal to 180/110 mmHg
• Confirmed or suspected of narcotic analgesics abusing or long term using
• Taking corticosteroids or immunosuppressive agents for more than 10 days with the previous 6 months or had history of adrenal suppression or immune system disease.
• Patients with thyroid hypofunction.
• Patients with history of asthma.
• Patients with history of surgery within previous 3 months.
• Patients allergic or contraindicated to propofol or etomidate
• Patients participated in other study within the last 30 days

Sponsors & Collaborators

• Zhihong LU: lead

Study Sites (1)

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (5)

• Du Y, Chen YJ, He B, Wang YW. The Effects of Single-Dose Etomidate Versus Propofol on Cortisol Levels in Pediatric Patients Undergoing Urologic Surgery: A Randomized Controlled Trial. Anesth Analg. 2015 Dec;121(6):1580-5. doi: 10.1213/ANE.0000000000000981.

  PMID: 26496368 BACKGROUND

• Aghdaii N, Ziyaeifard M, Faritus SZ, Azarfarin R. Hemodynamic Responses to Two Different Anesthesia Regimens in Compromised Left Ventricular Function Patients Undergoing Coronary Artery Bypass Graft Surgery: Etomidate-Midazolam Versus Propofol-Ketamine. Anesth Pain Med. 2015 Jun 22;5(3):e27966. doi: 10.5812/aapm.27966v2. eCollection 2015 Jun.

  PMID: 26161330 BACKGROUND

• Song JC, Lu ZJ, Jiao YF, Yang B, Gao H, Zhang J, Yu WF. Etomidate Anesthesia during ERCP Caused More Stable Haemodynamic Responses Compared with Propofol: A Randomized Clinical Trial. Int J Med Sci. 2015 Jul 3;12(7):559-65. doi: 10.7150/ijms.11521. eCollection 2015.

  PMID: 26180512 BACKGROUND

• Kaushal RP, Vatal A, Pathak R. Effect of etomidate and propofol induction on hemodynamic and endocrine response in patients undergoing coronary artery bypass grafting/mitral valve and aortic valve replacement surgery on cardiopulmonary bypass. Ann Card Anaesth. 2015 Apr-Jun;18(2):172-8. doi: 10.4103/0971-9784.154470.

  PMID: 25849685 BACKGROUND

• Lu Z, Zheng H, Chen Z, Xu S, Chen S, Mi W, Wang T, Chai X, Guo Q, Zhou H, Yu Y, Zheng X, Zhang J, Ai Y, Yu B, Bao H, Zheng H, Huang W, Wu A, Deng X, Ma H, Ma W, Tao L, Yang X, Zhang J, Liu T, Ma HP, Liang W, Wang X, Zhang Y, Du W, Ma T, Xie Y, Xie Y, Li N, Yang Y, Zheng T, Zhang C, Zhao Y, Dong R, Zhang C, Zhang G, Liu K, Wu Y, Fan X, Tan W, Li N, Dong H, Xiong L. Effect of Etomidate vs Propofol for Total Intravenous Anesthesia on Major Postoperative Complications in Older Patients: A Randomized Clinical Trial. JAMA Surg. 2022 Oct 1;157(10):888-895. doi: 10.1001/jamasurg.2022.3338.

  PMID: 35947398 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Etomidate; Propofol; Sufentanil; cisatracurium

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fentanyl; Piperidines

Study Officials

• Lize Xiong, PhD

  Xijing hosptial

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: participants were anesthetized and were unaware of the grouping. Care providers did not know the grouping. Specific investigators who did the intervention were aware of the grouping. The outcome assessors and the data analyzers did not know the grouping.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: September 21, 2016
• Study Start: August 15, 2017
• Primary Completion: November 20, 2019
• Study Completion: November 20, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)