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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,154
palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, fosaprepitant 150mg dissolved in 0.9% NaCl 150ml, iv.drip,
palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, 0.9% NaCl 150ml, iv.drip,
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Proportion of participants with PONV during the first 24 postoperative hours
PONV is defined as nausea, retching or vomiting
Time frame: from operation completion to 24-hour after surgery (up to 24 hours)
Proportion of participants with PONV
PONV is defined as nausea, retching or vomiting
Time frame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Proportion of participants with emetic episodes
Emetic episodes are defined as retching or vomiting or both
Time frame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Proportion of participants with nausea
Nausea is defined as a feeling of the urge to vomit
Time frame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Proportion of participants with rescue antiemetic medication
Rescue antiemetic medication
Time frame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
The severity of PONV
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
Time frame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Postoperative recovery score using 15-item quality of recovery scoring system(QoR-15) during each subsequent evaluation period (up to 120 hours)
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.
Time frame: evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery)
Pain scores
Pain scores are evaluated by numerical rating scale(NRS) from no pain(0) to most severe pain (10).
Time frame: evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery)
Time to first flatus after surgery
Time length between operation completion and the first flatus
Time frame: evaluated at the time of first exhaust after surgery(expected average of 3 days after surgery)
Time to first defecation after surgery
Time length between operation completion and the first defecation
Time frame: evaluated at the time of the first defecation after surgery(expected average of 6 days after surgery
Time to fulfill the criteria of hospital discharge (recovery time)
The ideal time point for discharge, which is also considered as recovery time.
Time frame: from operation completion to fulfill the criteria of hospital discharge(expected 6 days )
Health related quality of life
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.
Time frame: evaluated before surgery, at 120-hour and 30 days after surgery (up to 30 days）
Proportion of patients with adverse events (up to 30 days after surgery)
adverse events
Time frame: from drug administration to 30 days (30 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.