EPIC: Etomidate to Improve Outcome in Elderly Patients

Sponsor

Zhihong LU (Other)

Overall Status

Completed

CT.gov ID

NCT02910206

Collaborator

(none)

1,917

Enrollment

Location

Arms

39.2

Actual Duration (Months)

48.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Complications	Drug: Etomidate Drug: propofol Drug: Sufentanil Drug: Cisatracurium	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1917 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 15, 2017

Actual Primary Completion Date :

Nov 20, 2019

Actual Study Completion Date :

Nov 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: etomidate etomidate is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium	Drug: Etomidate etomidate is given intravenously Drug: Sufentanil sufentanil is given intravenously Drug: Cisatracurium Cisatracurium is given intravenously
Experimental: propofol propofol is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium	Drug: propofol propofol is given intravenously Drug: Sufentanil sufentanil is given intravenously Drug: Cisatracurium Cisatracurium is given intravenously

Arm

Intervention/Treatment

Experimental: etomidate

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

Drug: Etomidate

etomidate is given intravenously

Drug: Sufentanil

sufentanil is given intravenously

Drug: Cisatracurium

Cisatracurium is given intravenously

Experimental: propofol

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

Drug: propofol

propofol is given intravenously

Drug: Sufentanil

sufentanil is given intravenously

Drug: Cisatracurium

Cisatracurium is given intravenously

Outcome Measures

Primary Outcome Measures

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

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]
score:0,no nausea and vomiting; 1,nausea without vomiting; 2,vomiting
pain on visual analogue scale [6 hours after end of surgery，approximately 6 hours]
satisfaction on visual analogue scale by the patients [24 hours after end of surgery]
patients will be asked to score their satisfaction on anesthesia on a visual analogue, 0 is for extremely unsatisfied, 10 is for totally satisfied
comfort on visual analogue scale by the patients [24 hours after end of surgery]
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
incidence of hypotension during anesthesia [from start of surgery to end of surgery, on an average of 2.5 hours]
hypotension is defined as decrease of systemic blood pressure more than 20% of baseline
incidence of hypertension during anesthesia [from start of surgery to end of surgery, on an average of 2.5 hours]
hypotension is defined as increase of systemic blood pressure more than 20% of baseline
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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