Clinical trial NCT04853147: Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery
Official title: Triple Combination of Fosaprepitant, Dexamethasone and Palonosetron Versus Combination of Dexamethasone and Palonosetron for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastrointestinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: C.Surgical Procedure; Gastrointestinal
Keywords: postoperative nausea and vomiting, fosaprepitant,
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 1154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants with PONV during the first 24 postoperative hours
timeFrame: from operation completion to 24-hour after surgery (up to 24 hours)
Secondary outcomes:
measure: Proportion of participants with PONV
timeFrame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
measure: Proportion of participants with emetic episodes
timeFrame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
measure: Proportion of participants with nausea
timeFrame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
measure: Proportion of participants with rescue antiemetic medication
timeFrame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
measure: The severity of PONV
timeFrame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
measure: Postoperative recovery score using 15-item quality of recovery scoring system(QoR-15) during each subsequent evaluation period (up to 120 hours)
timeFrame: evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery)
measure: Pain scores
timeFrame: evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery)
measure: Time to first flatus after surgery
timeFrame: evaluated at the time of first exhaust after surgery(expected average of 3 days after surgery)
measure: Time to first defecation after surgery
timeFrame: evaluated at the time of the first defecation after surgery(expected average of 6 days after surgery
measure: Time to fulfill the criteria of hospital discharge (recovery time)
timeFrame: from operation completion to fulfill the criteria of hospital discharge(expected 6 days )
measure: Health related quality of life
timeFrame: evaluated before surgery, at 120-hour and 30 days after surgery (up to 30 days）
measure: Proportion of patients with adverse events (up to 30 days after surgery)
timeFrame: from drug administration to 30 days (30 days)
Other outcomes:
measure: Concentration of materials in blood such as hormone and metabolic
timeFrame: evaluated before surgery, at the end of surgery
measure: 6-month survival rate
timeFrame: 6-month after surgery
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sixth SunYetSen
name: Yang Zhao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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