Postoperative Complications
Conditions
Keywords
etomidate, propofol
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
Interventions
DRUGEtomidate
etomidate is given intravenously
DRUGpropofol
propofol is given intravenously
DRUGSufentanil
sufentanil is given intravenously
DRUGCisatracurium
Cisatracurium is given intravenously
Sponsors
Zhihong LU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| the time to awake from anesthesia | From stopping etomidate or propofol infusion to awake, approximately 30 minutes | — |
| 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 | — |
| 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 |
Countries
China
Outcome results
None listed