Effect of a Multimodal Antiemetic Protocol on Postoperative Nausea and Vomiting in Patients Undergoing Flap Surgery for Head and Neck Cancer

NCT07786155 | Not Yet Recruiting

• 1 other identifier: 2606-122-1756
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Number of Episodes of Moderate-to-Severe Postoperative Nausea and Vomiting Requiring Rescue Antiemetics

  The number of episodes of moderate-to-severe postoperative nausea and vomiting requiring rescue antiemetic medication within 3 days after surgery.

  Within 72 hours after surgery

Secondary Outcomes (3)

• Quality of Recovery (QoR-15K) Score

  Preoperatively and on postoperative days 1, 2, and 3

• Postoperative Nausea and Vomiting Severity

  24, 48, and 72 hours after surgery

• Postoperative Pain Score

  24, 48, and 72 hours after surgery

Study Arms (2)

Control group

ACTIVE COMPARATOR

Patients receive inhalational anesthesia with sevoflurane and remifentanil. Dexamethasone 5 mg is administered intravenously 1 hour before the end of surgery.

Other: Standard antiemetic and anesthetic protocol

Multimodal group

EXPERIMENTAL

After anesthesia induction, an ultrasound-guided superficial cervical plexus block is performed using 10 mL of 0.75% ropivacaine on the surgical side of the neck. Total intravenous anesthesia with propofol and remifentanil is used for maintenance. Dexamethasone 5 mg, palonosetron 0.075 mg, and acetaminophen 1 g are administered intravenously 1 hour before the end of surgery.

Other: Multimodal antiemetic and anesthetic protocol

Interventions

Standard antiemetic and anesthetic protocol OTHER

Patients receive general anesthesia maintained with sevoflurane and remifentanil. Dexamethasone 5 mg is administered intravenously 1 hour before the end of surgery.

Control group

Multimodal antiemetic and anesthetic protocol OTHER

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.

Multimodal group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 19 years or older undergoing elective flap surgery for head and neck cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 26, 2026

Record last verified: 2026-08