Etomidate to Improve Outcome in Elderly Patients

Postoperative Complications Clinical Trial

— EPIC  

Official title:

Comparative Effect of Etomidate and Propofol on Major Complications After Abdominal Surgery in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910206
• Other study ID #: XJH-A-2015-12-01
• Status: Completed
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: November 20, 2020

Study information

• Verified date: December 2020
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1917
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Drug:
• Etomidate
etomidate is given intravenously
• propofol
propofol is given intravenously
• Sufentanil
sufentanil is given intravenously
• Cisatracurium
Cisatracurium is given intravenously

Locations

Country	Name	City	State
China	Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Zhihong LU

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the time to awake from anesthesia		From stopping etomidate or propofol infusion to awake, approximately 30 minutes
Secondary	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
Secondary	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
Secondary	the time to discharge from hospital		From end of surgery to discharge from hospital,on an average of 7 days
Secondary	Post Operative Nausea And vomiting score	score:0,no nausea and vomiting; 1,nausea without vomiting; 2,vomiting	6 hours, 24 hours, 48 hours and 72 hours after end of surgery,approximately 6 hours, 24 hours, 48 hours and 72 hours respectively
Secondary	pain on visual analogue scale		6 hours after end of surgery,approximately 6 hours
Secondary	satisfaction on visual analogue scale by the patients	patients will be asked to score their satisfaction on anesthesia on a visual analogue, 0 is for extremely unsatisfied, 10 is for totally satisfied	24 hours after end of surgery
Secondary	comfort on visual analogue scale by the patients	patients will be asked to score their comfort during and after anesthesia on a visual analogue, 0 is for extremely unsatisfied, 10 is for totally satisfied	24 hours after end of surgery
Secondary	incidence of hypotension during anesthesia	hypotension is defined as decrease of systemic blood pressure more than 20% of baseline	from start of surgery to end of surgery, on an average of 2.5 hours
Secondary	incidence of hypertension during anesthesia	hypotension is defined as increase of systemic blood pressure more than 20% of baseline	from start of surgery to end of surgery, on an average of 2.5 hours
Secondary	percentage of patients needed vasoactive agents during anesthesia		from start of surgery to end of surgery, on an average of 2.5 hours
Secondary	concentration of serum Cortisol by radioimmunoassay		24hours,48hours and 72hours after extubation,approximately 24 hour, 48 hour and 72 hour respectively
Secondary	concentration of serum aldosterone by radioimmunoassay		24hours,48hours and 72hours after extubation,approximately 24 hour, 48 hour and 72 hour respectively
Secondary	concentration of serum Adrenocorticotropichormone(ACTH) by radioimmunoassay		24hours,48hours and 72hours after extubation,approximately 24 hour, 48 hour and 72 hour respectively
Secondary	death by 6 months after surgery		from end of surgery to 6 months after surgery
Secondary	death by 12 months after surgery		from end of surgery to 12 months after surgery