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Completed

NCT Number: NCT02910206

Etomidate to Improve Outcome 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

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etomidate

Drug

etomidate is given intravenously

Propofol

Drug

propofol is given intravenously

Sufentanil

Drug

sufentanil is given intravenously

Cisatracurium

Drug

Cisatracurium is given intravenously

Primary outcomes

  1. 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 outcomes

  1. the time to awake from anesthesia

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

  2. 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

  3. 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

  4. the time to discharge from hospital

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

  5. 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

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

  6. pain on visual analogue scale

    Time frame: 6 hours after end of surgery，approximately 6 hours

  7. satisfaction on visual analogue scale by the patients

    Time frame: 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

  8. comfort on visual analogue scale by the patients

    Time frame: 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

  9. incidence of hypotension during anesthesia

    Time frame: 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

  10. incidence of hypertension during anesthesia

    Time frame: 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

  11. 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

  12. concentration of serum Cortisol by radioimmunoassay

    Time frame: 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively

  13. concentration of serum aldosterone by radioimmunoassay

    Time frame: 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively

  14. concentration of serum Adrenocorticotropichormone(ACTH) by radioimmunoassay

    Time frame: 24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively

  15. death by 6 months after surgery

    Time frame: from end of surgery to 6 months after surgery

  16. death by 12 months after surgery

    Time frame: from end of surgery to 12 months after surgery

Sponsors and collaborators

Lead sponsor

Zhihong LU

Other

Registry information

Official study title

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

Acronym: EPIC

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 21, 2016
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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