Etomidate to Improve Outcome in Elderly Patients

Study Overview
=================
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

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

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Drug: Etomidate
* Drug: propofol
* Drug: Sufentanil
* Drug: Cisatracurium


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: etomidate<br>etomidate is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium | Drug: Etomidate<br>* etomidate is given intravenously<br>Drug: Sufentanil<br>* sufentanil is given intravenously<br>Drug: Cisatracurium<br>* Cisatracurium is given intravenously<br>|
| Experimental: propofol<br>propofol is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium | Drug: propofol<br>* propofol is given intravenously<br>Drug: Sufentanil<br>* sufentanil is given intravenously<br>Drug: Cisatracurium<br>* Cisatracurium is given intravenously<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 
| pain on visual analogue scale |  | 6 hours after end of surgery，approximately 6 hours | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| percentage of patients needed vasoactive agents during anesthesia |  | from start of surgery to end of surgery, on an average of 2.5 hours | 
| concentration of serum Cortisol by radioimmunoassay |  | 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively | 
| concentration of serum aldosterone by radioimmunoassay |  | 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively | 
| concentration of serum Adrenocorticotropichormone(ACTH) by radioimmunoassay |  | 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively | 
| death by 6 months after surgery |  | from end of surgery to 6 months after surgery | 
| death by 12 months after surgery |  | from end of surgery to 12 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
etomidate, propofol