Phase 4
N=100
Desflurane or Propofol Anesthesia in Elderly Obese Patients Undergoing Total Knee Replacement
Obesity · Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01270620 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Assessment of Delirium — 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- propofol (Drug); Desflurane (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Pedro Paulo Tanaka
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Delirium |
0; 0 | — |
| PRIMARY Recall of Digit Span |
10; 9 | — |
| PRIMARY Recall of Digit Span |
10; 9 | — |
| PRIMARY Digit Symbol Substitution Test |
24; 16 | — |
| PRIMARY Digit Symbol Substitution Test |
24; 16 | — |
| PRIMARY Trail Making Part A |
26; 19 | — |
| PRIMARY Trail Making Part A |
26; 19 | — |
| PRIMARY Trail Making Part B |
29; 22 | — |
| PRIMARY Trail Making Part B |
29; 22 | — |
| SECONDARY - Time to Spontaneous Breathing After Desflurane/Propofol Discontinuation |
270; 300 | — |
| SECONDARY - Time to Eye Opening After Desflurane/Propofol Discontinuation |
420; 395 | — |
| SECONDARY - Time to Tracheal Extubation After Desflurane/Propofol Discontinuation |
420; 526 | — |
| SECONDARY - Time to Following Command After Desflurane/Propofol Discontinuation |
480; 450 | — |
| SECONDARY Nausea and Vomiting |
3; 4 | — |
| SECONDARY Recovery Room Time |
65; 60.5 | — |
| SECONDARY B-type Natriuretic Peptide |
47; 43 | — |
| SECONDARY N-terminal proBNP |
83; 86 | — |
| SECONDARY Troponin I |
1; 0 | — |
| SECONDARY BNP |
83.5; 92 | — |
| SECONDARY ProBNP |
330; 311.5 | — |
| SECONDARY Duration of Surgery |
103.5; 95 | — |
| SECONDARY Duration of Anesthesia |
137.5; 133.5 | — |
| SECONDARY Amount of Intraoperative Fentanyl |
350; 350 | — |
Summary
You are invited to participate in a research study assessing your mental status in the first days after your surgery and how you will be doing in the 2 years following the surgery. The investigators hope to learn more about the incidence of postoperative confusion and a possible relation with 2 anesthesia techniques that are routinely used. The first one is an anesthesia technique that uses the inhaled anesthetic gas desflurane and the second one is an anesthesia technique that uses the anesthetic propofol administered by infusion in a vein. The investigators are also looking to see if there is a relationship between anesthesia technique and cardiovascular outcomes. You were selected as a possible participant in this study because at your age this phenomenon appears to have a greater incidence.
Eligibility Criteria
Inclusion Criteria
- Age > 65 years old
- Body mass index > 30 kg/m2
- Undergoing primary total knee arthroplasty surgery
- American society of anesthesiology classification II-III
Exclusion Criteria
- Patient refusal to participate in the study
- Patient refusal or failure of regional block
- Patients with preexisting neuro-cognitive disorders
- Known intolerance to any of the drugs to be used according to the study protocol
Data sourced from ClinicalTrials.gov (NCT01270620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.