C.Surgical Procedure; Gastrointestinal
Conditions
Keywords
postoperative nausea and vomiting, fosaprepitant,
Brief summary
Postoperative nausea and vomiting (PONV) are common in patients, especially in patients at high risk. PONV may result in prolonged hospital stay and threaten patients' life. Because the etiology of PONV is very complex, there is an increasing focus on combining antiemetics from different classes for PONV prophylaxis. Fosaprepitant is a neurokinin-1 (NK-1) receptor antagonist to prevent PONV. Palonosetron is a 5-HT3 receptor antagonist with high efficacy and sustained action for PONV prophylaxis. Dexamethasone belongs to corticosteroid and also has the ability to reduce the incident of PONV. This study aims to use the combination of these three drugs in high-risk patients to test whether triple therapy is better than combination of palonosetron and dexamethasone to prevent PONV.
Detailed description
This trial is a prospective, randomized controlled study with blinded participant, care provider, investigator, and outcomes assessor. 1154 patients aged 18 to 75 years undergoing laparoscopic gastrointestinal surgery will be enrolled.Triple therapy of palonosetron and dexamethasone plus fosaprepitant will be administered in the intervention group, and double therapy of palonosetron and dexamethasone will be used in the control group. The anxiety of patients will be evaluated. The primary outcome is proportion of participants with PONV during the first 24 postoperative hours. Secondary outcomes are as follow: proportion of participants with PONV,emetic episodes, nausea, with rescue antiemetic medication; the scores of QOR-15; pain scores;time to first flatus after surgery; time to first defecation after surgery; recovery time; health related quality of life; proportion of participants with adverse events.
Interventions
DRUGpalonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl
palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, fosaprepitant 150mg dissolved in 0.9% NaCl 150ml, iv.drip,
DRUGpalonosetron, dexamethasone, and 0.9% NaCl
palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, 0.9% NaCl 150ml, iv.drip,
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years and Age ≤75 years; * Scheduled for laparoscopic gastrointestinal surgical procedure with general anesthesia ; * The score evaluated by Apfel simplified PONV risk assessment systems is ≥3.
Exclusion criteria
* The American Society of Anesthesiologists (ASA) rating is \>3; * Severe hepatic dysfunction(the score of Child-Pugh is \>9); * With contraindications for using fosaprepitant, 5-HT3 receptor antagonist or dexamethasone ; * Take medications with known antiemetic properties preoperatively ; * With mental disorder, or not be able to communicate ; * Pregnant women or nursing mothers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with PONV during the first 24 postoperative hours | from operation completion to 24-hour after surgery (up to 24 hours) | PONV is defined as nausea, retching or vomiting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with PONV | calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery) | PONV is defined as nausea, retching or vomiting |
| Proportion of participants with emetic episodes | calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery) | Emetic episodes are defined as retching or vomiting or both |
| Proportion of participants with nausea | calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery) | Nausea is defined as a feeling of the urge to vomit |
| Proportion of participants with rescue antiemetic medication | calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery) | Rescue antiemetic medication |
| The severity of PONV | calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery) | The severity of PONV is evaluated by a PONV impact scale score. Nausea intensity is scored as 1 ,2 ,3. In addition, vomiting intensity is scored as the number of vomits (0-2, or 3 if three or more vomits). Both scores together to obtain the PONV impact scale score |
| Postoperative recovery score using 15-item quality of recovery scoring system(QoR-15) during each subsequent evaluation period (up to 120 hours) | evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery) | The QoR-15 comprises five subscales: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10, and the possible total score ranges from 0 to 150. A higher total score means better patient QoR. |
| Health related quality of life | evaluated before surgery, at 120-hour and 30 days after surgery (up to 30 days） | Health related quality of life is measured by EQ-5D. Each EQ-5D health state can be coded into a five-digit number using the numbers 1 , 2 , and 3 to indicate the functional levels of the five dimensions. |
| Proportion of patients with adverse events (up to 30 days after surgery) | from drug administration to 30 days (30 days) | adverse events |
| Pain scores | evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery) | Pain scores are evaluated by numerical rating scale(NRS) from no pain(0) to most severe pain (10). |
| Time to first flatus after surgery | evaluated at the time of first exhaust after surgery(expected average of 3 days after surgery) | Time length between operation completion and the first flatus |
| Time to first defecation after surgery | evaluated at the time of the first defecation after surgery(expected average of 6 days after surgery | Time length between operation completion and the first defecation |
| Time to fulfill the criteria of hospital discharge (recovery time) | from operation completion to fulfill the criteria of hospital discharge(expected 6 days ) | The ideal time point for discharge, which is also considered as recovery time. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Concentration of materials in blood such as hormone and metabolic | evaluated before surgery, at the end of surgery | materials in blood |
| 6-month survival rate | 6-month after surgery | survival rate in 6-month after surgery |
Countries
China
Outcome results
None listed