Postoperative Nausea and Vomiting
Conditions
Brief summary
This prospective randomized controlled trial evaluates whether a multimodal antiemetic protocol can reduce postoperative nausea and vomiting (PONV) in patients undergoing flap surgery for head and neck cancer. Seventy-two patients will be randomized to receive either standard dexamethasone-based prophylaxis or a multimodal protocol incorporating TIVA, superficial cervical plexus block, palonosetron, dexamethasone, and acetaminophen. PONV, postoperative pain, quality of recovery, and other postoperative outcomes will be compared.
Interventions
OTHERStandard antiemetic and anesthetic protocol
Patients receive general anesthesia maintained with sevoflurane and remifentanil. Dexamethasone 5 mg is administered intravenously 1 hour before the end of surgery.
OTHERMultimodal antiemetic and anesthetic protocol
The multimodal protocol consists of total intravenous anesthesia with propofol and remifentanil, ultrasound-guided superficial cervical plexus block with 10 mL of 0.75% ropivacaine, and intravenous administration of dexamethasone 5 mg, palonosetron 0.075 mg, and acetaminophen 1 g 1 hour before the end of surgery.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 19 years or older undergoing elective flap surgery for head and neck cancer
Exclusion criteria
* Patients who do not consent to participate in the study * Patients undergoing emergency surgery * Patients with signs of inflammation (such as erythema) at the nerve block injection site * Patients with a history of hypersensitivity or adverse reactions to ropivacaine * Patients with difficulty completing questionnaires due to conditions such as dementia or delirium * Patients with severe cardiopulmonary disease * Patients with QT prolongation on preoperative ECG Patients deemed unsuitable for participation by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Episodes of Moderate-to-Severe Postoperative Nausea and Vomiting Requiring Rescue Antiemetics | Within 72 hours after surgery | The number of episodes of moderate-to-severe postoperative nausea and vomiting requiring rescue antiemetic medication within 3 days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Nausea and Vomiting Severity | 24, 48, and 72 hours after surgery | Severity of postoperative nausea and vomiting assessed at 24, 48, and 72 hours after surgery using a 4-point scale (0: none, 1: mild, 2: moderate, 3: severe). |
| Postoperative Pain Score | 24, 48, and 72 hours after surgery | Postoperative pain assessed at 24, 48, and 72 hours after surgery using the 11-point Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain severity. |
| Quality of Recovery (QoR-15K) Score | Preoperatively and on postoperative days 1, 2, and 3 | Quality of recovery assessed using the Korean version of the 15-item Quality of Recovery questionnaire (QoR-15K) before surgery and on postoperative days 1, 2, and 3. The QoR-15K score ranges from 0 to 150, with higher scores indicating better recovery. |
Outcome results
None listed