Osteoarthritis, Knee
Conditions
Keywords
postoperative nausea and vomiting
Brief summary
The purposes of this study are to document the antiemetic efficacy of multimodal antiemetic protocol in patient after Total Knee Arthroplasty using regional anesthesia, midazolam & propofol, hydration & oxygen supplement, preemptive & multimodal contemporary pain management and to determine whether Ramosetron prophylaxis would provide additional antiemetic effect on this protocol. We hypothesized that the incidence of Postoperative nausea and vomiting during multimodal antiemetic protocol would be lower than Apfel's expected postoperative nausea and vomiting incidence. It was also hypothesized that Ramosetron prophylaxis would provide additional antiemetic effect.
Detailed description
Immediate postoperative pain after Total Knee Arthroplasty(TKA) remains an unsolved problem, and a substantial proportion of patients experience moderate to severe postoperative pain. Patient controlled analgesia(PCA) using opioid is an effective and safe modality for postoperative pain relief after TKA and remains an integral part of pain management after TKA. However, Opioid is associated with high incidence of postoperative nausea and vomiting(PONV) which is the most frequent complication during the first 24 hour after surgery.PONV has been reported to be more distressing than postoperative pain and to be the most undesirable negative outcome. Despite advances in prevention and treatment of PONV, PONV remains a continuing problem with an incidence of 20-30% in unselected patients and up to 70% in high-risk patients. As results of current researches, some risk factors of PONV have been identified and indications of prophylactic antiemetics and strategies to reduce baseline risk have been recommended.The recommended modalities to reduce baseline risk includes regional anesthesia, oxygen supplement, use of midazolam and propofol and avoid use of inhaled anesthesia and neuromuscular blockade. In addition,published evidence suggests that appropriate antiemetic prophylaxis should be considered for patients with 2 or more risk factors and to reduce opioid consumption, preemptive multimodal pain management such as preemptive analgesic medication, continuous regional nerve block is recommended.Ramosetron is a newly developed serotonin receptor antagonist with a higher affinity and longer duration of action than that of the previously developed serotonin receptor antagonist such as ondansetron and granisetron. Thus, this prospective blinded randomized study was conducted to document the antiemetic efficacy of multimodal antiemetic protocol to reduce baseline risk, using regional anesthesia, midazolam and propofol, hydration and oxygen supplement and multimodal pain control protocols using the continuous femoral nerve block, PCA and preemptive oral medications and to determine whether Ramosetron prophylaxis would provide additional antiemetic effect in patients after TKA for whom covered by this multimodal antiemetic protocols.
Interventions
DRUGRamosetron
ramosetron intravenous injection, 0.3mg, 1 time/day for 2 days
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 86 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary osteoarthritis, knee * Scheduled for elective total knee arthroplasty * Signed written informed consent
Exclusion criteria
* Refusing participate * Contraindication to regional anesthesia * Severe impairment of bowel motility * administration of other antiemetics within 24hours before surgery * systemic steroid within 24hours before surgery * history of cardiovascular & respiratory disease * renal & hepatic failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Nausea and Vomiting | within 48 hours after surgery | outcomes assessor who is blinded to randomization assessed the incidence of postoperative nausea which was defined as subjectively unpleasant sensation associated with awareness of the urge to vomit and an emetic episode and vomiting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Rescue Antiemetic Administration | within 48 hours after surgery | outcome assessor assessed the incidence of rescue antiemetic administration |
Countries
South Korea
Participant flow
Recruitment details
153 patients whose diagnosis was primary osteoarthritis scheduled for unilateral total knee arthroplasty(TKA)at Seoul National University Bundang Hospital from October 2009 to March 2010 were recruited.
Pre-assignment details
11 patients were excluded before assignment. 6 were other diagnosis such as rheumatoid arthritis, secondary osteoarthritis, 2 were refused to participate this study, and 3 were serious medical conditions such as respiratory failure, heart failure.
Participants by arm
| Arm | Count |
|---|---|
| Ramosetron Prophylaxis ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery | 71 |
| Control no antiemetic prophylaxis | 71 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 11 | 12 |
Baseline characteristics
| Characteristic | Control | Ramosetron Prophylaxis | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 55 Participants | 58 Participants | 113 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 13 Participants | 29 Participants |
| Age Continuous | 69.0 years STANDARD_DEVIATION 7.5 | 69.1 years STANDARD_DEVIATION 6.3 | 69.1 years STANDARD_DEVIATION 6.8 |
| Region of Enrollment Korea, Republic of | 71 participants | 71 participants | 142 participants |
| Sex: Female, Male Female | 65 Participants | 64 Participants | 129 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 71 | 2 / 71 |
| serious Total, serious adverse events | 27 / 71 | 25 / 71 |
Outcome results
Primary
Incidence of Nausea and Vomiting
outcomes assessor who is blinded to randomization assessed the incidence of postoperative nausea which was defined as subjectively unpleasant sensation associated with awareness of the urge to vomit and an emetic episode and vomiting
Time frame: within 48 hours after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ramosetron Prophylaxis | Incidence of Nausea and Vomiting | 25 participants |
| Control | Incidence of Nausea and Vomiting | 32 participants |
p-value: <0.05t-test, 2 sided
Secondary
Incidence of Rescue Antiemetic Administration
outcome assessor assessed the incidence of rescue antiemetic administration
Time frame: within 48 hours after surgery