MedDataX Logo

Etomidate to Improve Outcome in Elderly Patients

NCT ID: NCT02910206

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1917 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2020-11-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Complications

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

etomidate propofol

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

etomidate

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

Group Type EXPERIMENTAL

Etomidate

Intervention Type DRUG

etomidate is given intravenously

Sufentanil

Intervention Type DRUG

sufentanil is given intravenously

Cisatracurium

Intervention Type DRUG

Cisatracurium is given intravenously

propofol

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

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

propofol is given intravenously

Sufentanil

Intervention Type DRUG

sufentanil is given intravenously

Cisatracurium

Intervention Type DRUG

Cisatracurium is given intravenously

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Etomidate

etomidate is given intravenously

Intervention Type DRUG

propofol

propofol is given intravenously

Intervention Type DRUG

Sufentanil

sufentanil is given intravenously

Intervention Type DRUG

Cisatracurium

Cisatracurium is given intravenously

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zhihong LU

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhihong LU

Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lize Xiong, PhD

Role: STUDY_CHAIR

Xijing hosptial

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26496368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26161330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26180512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25849685 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35947398 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XJH-A-2015-12-01

Identifier Type: -

Identifier Source: org_study_id