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Etomidate to Improve Outcome in Elderly Patients (EPIC)

Primary Purpose

Postoperative Complications

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Etomidate

propofol

Sufentanil

Cisatracurium

About this trial

This is an interventional treatment trial for Postoperative Complications focused on measuring etomidate, propofol

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

Xijing Hospital, Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

etomidate

propofol

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of participants with complications defined by ICD (International codes of diseases)-9

Secondary Outcome Measures

the time to awake from anesthesia

the time to withdraw tracheal tube from anesthesia

the time to discharge from post-anesthesia care unit

the time to discharge from hospital

Post Operative Nausea And vomiting score

score:0,no nausea and vomiting; 1,nausea without vomiting; 2,vomiting

pain on visual analogue scale

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

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

incidence of hypotension during anesthesia

hypotension is defined as decrease of systemic blood pressure more than 20% of baseline

incidence of hypertension during anesthesia

hypotension is defined as increase of systemic blood pressure more than 20% of baseline

percentage of patients needed vasoactive agents during anesthesia

concentration of serum Cortisol by radioimmunoassay

concentration of serum aldosterone by radioimmunoassay

concentration of serum Adrenocorticotropichormone(ACTH) by radioimmunoassay

death by 6 months after surgery

death by 12 months after surgery

Full Information

NCT ID

NCT02910206

First Posted

June 30, 2016

Last Updated

December 9, 2020

Sponsor

Zhihong LU

1. Study Identification

Unique Protocol Identification Number

NCT02910206

Brief Title

Etomidate to Improve Outcome in Elderly Patients

Acronym

EPIC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

August 15, 2017 (Actual)

Primary Completion Date

November 20, 2019 (Actual)

Study Completion Date

November 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zhihong LU

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Complications

Keywords

etomidate, propofol

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes 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.

Allocation

Randomized

Enrollment

1917 (Actual)

8. Arms, Groups, and Interventions

Arm Title

etomidate

Arm Type

Experimental

Arm Description

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

Arm Title

propofol

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Etomidate

Intervention Description

etomidate is given intravenously

Intervention Type

Drug

Intervention Name(s)

propofol

Intervention Description

propofol is given intravenously

Intervention Type

Drug

Intervention Name(s)

Sufentanil

Intervention Description

sufentanil is given intravenously

Intervention Type

Drug

Intervention Name(s)

Cisatracurium

Intervention Description

Cisatracurium is given intravenously

Primary Outcome Measure Information:

Title

Number of participants with complications defined by ICD (International codes of diseases)-9

Time Frame

From the moment of giving sufentanil to the moment of discharge from hospital,up to 7 days

Secondary Outcome Measure Information:

Title

the time to awake from anesthesia

Time Frame

From stopping etomidate or propofol infusion to awake, approximately 30 minutes

Title

the time to withdraw tracheal tube from anesthesia

Time Frame

From end of etomidate or propofol infusion to recovery of spontaneous breathing and withdrawal of tracheal tube,approximately 30 minutes

Title

the time to discharge from post-anesthesia care unit

Time Frame

From admit into post-anesthesia care unit to discharge from post-anesthesia care unit,on an average of 30 minutes

Title

the time to discharge from hospital

Time Frame

From end of surgery to discharge from hospital,on an average of 7 days

Title

Post Operative Nausea And vomiting score

Description

score:0,no nausea and vomiting; 1,nausea without vomiting; 2,vomiting

Time Frame

6 hours, 24 hours, 48 hours and 72 hours after end of surgery，approximately 6 hours, 24 hours, 48 hours and 72 hours respectively

Title

pain on visual analogue scale

Time Frame

6 hours after end of surgery，approximately 6 hours

Title

satisfaction on visual analogue scale by the patients

Description

patients will be asked to score their satisfaction on anesthesia on a visual analogue, 0 is for extremely unsatisfied, 10 is for totally satisfied

Time Frame

24 hours after end of surgery

Title

comfort on visual analogue scale by the patients

Description

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

Time Frame

24 hours after end of surgery

Title

incidence of hypotension during anesthesia

Description

hypotension is defined as decrease of systemic blood pressure more than 20% of baseline

Time Frame

from start of surgery to end of surgery, on an average of 2.5 hours

Title

incidence of hypertension during anesthesia

Description

hypotension is defined as increase of systemic blood pressure more than 20% of baseline

Time Frame

from start of surgery to end of surgery, on an average of 2.5 hours

Title

percentage of patients needed vasoactive agents during anesthesia

Time Frame

from start of surgery to end of surgery, on an average of 2.5 hours

Title

concentration of serum Cortisol by radioimmunoassay

Time Frame

24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively

Title

concentration of serum aldosterone by radioimmunoassay

Time Frame

24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively

Title

concentration of serum Adrenocorticotropichormone(ACTH) by radioimmunoassay

Time Frame

24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively

Title

death by 6 months after surgery

Time Frame

from end of surgery to 6 months after surgery

Title

death by 12 months after surgery

Time Frame

from end of surgery to 12 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lize Xiong, PhD

Organizational Affiliation

Xijing hosptial

Official's Role

Study Chair

Facility Information:

Facility Name

Xijing Hospital, Fourth Military Medical University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26496368

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.

Results Reference

background

PubMed Identifier

26161330

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.

Results Reference

background

PubMed Identifier

26180512

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.

Results Reference

background

PubMed Identifier

25849685

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.

Results Reference

background

PubMed Identifier

35947398

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.

Results Reference

derived

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Etomidate to Improve Outcome in Elderly Patients

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