Postoperative ComplicationsEPICNCT02910206
Etomidate to Improve Outcome in Elderly Patients
A study testing Etomidate, propofol and Sufentanil in people with Postoperative Complications, run by Zhihong LU at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Etomidate, propofol and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,917 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2017to 20 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged between 65 and 80 years old.
- Patients scheduled for elective gastrointestinal surgery under general anesthesia.
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Comparative Effect of Etomidate and Propofol on Major Complications After Abdominal Surgery in Elderly Patients
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
- Conditions
- Postoperative Complications
- Being tested
- Etomidate, propofol, Sufentanil, Cisatracurium
- Keywords
- etomidate, propofol
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
etomidate is given intravenously
propofolDrug
propofol is given intravenously
SufentanilDrug
sufentanil is given intravenously
CisatracuriumDrug
Cisatracurium is given intravenously
| Study group | Role | What they receive |
|---|---|---|
| etomidate | Experimental | etomidate is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium Receives: Drug: Etomidate; Drug: Sufentanil; Drug: Cisatracurium |
| propofol | Experimental | propofol is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium Receives: Drug: propofol; Drug: Sufentanil; Drug: Cisatracurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with complications defined by ICD (International codes of diseases)-9
Measured: From the moment of giving sufentanil to the moment of discharge from hospital,up to 7 days
Secondary outcomes (16)
the time to awake from anesthesia
Measured: From stopping etomidate or propofol infusion to awake, approximately 30 minutes
the time to withdraw tracheal tube from anesthesia
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: from start of surgery to end of surgery, on an average of 2.5 hours
percentage of patients needed vasoactive agents during anesthesia
Measured: from start of surgery to end of surgery, on an average of 2.5 hours
concentration of serum Cortisol by radioimmunoassay
Measured: 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively
concentration of serum aldosterone by radioimmunoassay
Measured: 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively
concentration of serum Adrenocorticotropichormone(ACTH) by radioimmunoassay
Measured: 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively
death by 6 months after surgery
Measured: from end of surgery to 6 months after surgery
death by 12 months after surgery
Measured: from end of surgery to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start15 Aug 2017
- Primary completion20 Nov 2019
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,917 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhihong LU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhihong LU, Air Force Military Medical University, China
- Investigators
- Lize Xiong, PhD, Study chair, Xijing hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910206
- Sponsor's protocol ID
- XJH-A-2015-12-01
- Acronym
- EPIC
- Status last verified
- Dec 2020
- First submitted
- 30 Jun 2016
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26496368Aghdaii 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.
PubMed 26161330Song 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.
PubMed 26180512Kaushal 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.
PubMed 25849685Lu 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.
PubMed 35947398
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Etomidate and Propofol on Major Complications After Abdominal Surgery in Elderly Patients
- ClinicalTrials.gov ID
- NCT02910206
- Acronym / sponsor ID
- EPIC / XJH-A-2015-12-01
- Conditions
- Postoperative Complications
- Keywords
- etomidate, propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,917 participants (actual)
- Lead sponsor
- Zhihong LUUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etomidate | Experimental | Drug: Etomidate, Drug: Sufentanil, Drug: Cisatracuriumetomidate is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium |
| propofol | Experimental | Drug: propofol, Drug: Sufentanil, Drug: Cisatracuriumpropofol is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Aged between 65 and 80 years old.
- Patients scheduled for elective gastrointestinal surgery under general anesthesia.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etomidateetomidate is given intravenously | Drug | etomidate |
| propofolpropofol is given intravenously | Drug | propofol |
| Sufentanilsufentanil is given intravenously | Drug | etomidate, propofol |
| CisatracuriumCisatracurium is given intravenously | Drug | etomidate, propofol |
Primary outcome
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
16 secondary outcomes
the time to awake from anesthesia
Time frame: From stopping etomidate or propofol infusion to awake, approximately 30 minutes
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
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
the time to discharge from hospital
Time frame: From end of surgery to discharge from hospital,on an average of 7 days
Post Operative Nausea And vomiting score
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
pain on visual analogue scale
Time frame: 6 hours after end of surgery，approximately 6 hours
satisfaction on visual analogue scale by the patients
Time frame: 24 hours after end of surgery
comfort on visual analogue scale by the patients
Time frame: 24 hours after end of surgery
incidence of hypotension during anesthesia
Time frame: from start of surgery to end of surgery, on an average of 2.5 hours
incidence of hypertension during anesthesia
Time frame: from start of surgery to end of surgery, on an average of 2.5 hours
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
concentration of serum Cortisol by radioimmunoassay
Time frame: 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively
concentration of serum aldosterone by radioimmunoassay
Time frame: 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively
concentration of serum Adrenocorticotropichormone(ACTH) by radioimmunoassay
Time frame: 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively
death by 6 months after surgery
Time frame: from end of surgery to 6 months after surgery
death by 12 months after surgery
Time frame: from end of surgery to 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Background: PubMed 26496368Du 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.
- Background: PubMed 26161330Aghdaii 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.
- Background: PubMed 26180512Song 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.
- Background: PubMed 25849685Kaushal 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.
- Derived from this study: PubMed 35947398Lu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lize Xiong, PhD study chair
Xijing hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etomidate, propofol and Sufentanil in people with Postoperative Complications, run by Zhihong LU at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02910206, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.