Clinical trial NCT02910206: Etomidate to Improve Outcome in Elderly Patients
Official title: Comparative Effect of Etomidate and Propofol on Major Complications After Abdominal Surgery in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Keywords: etomidate
propofol
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 1917
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with complications defined by ICD (International codes of diseases)-9
timeFrame: From the moment of giving sufentanil to the moment of discharge from hospital,up to 7 days
Secondary outcomes:
measure: the time to awake from anesthesia
timeFrame: From stopping etomidate or propofol infusion to awake, approximately 30 minutes
measure: the time to withdraw tracheal tube from anesthesia
timeFrame: From end of etomidate or propofol infusion to recovery of spontaneous breathing and withdrawal of tracheal tube,approximately 30 minutes
measure: the time to discharge from post-anesthesia care unit
timeFrame: From admit into post-anesthesia care unit to discharge from post-anesthesia care unit,on an average of 30 minutes
measure: the time to discharge from hospital
timeFrame: From end of surgery to discharge from hospital,on an average of 7 days
measure: Post Operative Nausea And vomiting score
timeFrame: 6 hours, 24 hours, 48 hours and 72 hours after end of surgery，approximately 6 hours, 24 hours, 48 hours and 72 hours respectively
measure: pain on visual analogue scale
timeFrame: 6 hours after end of surgery，approximately 6 hours
measure: satisfaction on visual analogue scale by the patients
timeFrame: 24 hours after end of surgery
measure: comfort on visual analogue scale by the patients
timeFrame: 24 hours after end of surgery
measure: incidence of hypotension during anesthesia
timeFrame: from start of surgery to end of surgery, on an average of 2.5 hours
measure: incidence of hypertension during anesthesia
timeFrame: from start of surgery to end of surgery, on an average of 2.5 hours
measure: percentage of patients needed vasoactive agents during anesthesia
timeFrame: from start of surgery to end of surgery, on an average of 2.5 hours
measure: concentration of serum Cortisol by radioimmunoassay
timeFrame: 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively
measure: concentration of serum aldosterone by radioimmunoassay
timeFrame: 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively
measure: concentration of serum Adrenocorticotropichormone(ACTH) by radioimmunoassay
timeFrame: 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively
measure: death by 6 months after surgery
timeFrame: from end of surgery to 6 months after surgery
measure: death by 12 months after surgery
timeFrame: from end of surgery to 12 months after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Xijing hosptial
name: Lize Xiong, PhD
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
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.
citation: 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.