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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard antiemetic and anesthetic protocol

    Other intervention

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

  • Multimodal antiemetic and anesthetic protocol

    Other intervention

    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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Multimodal groupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Within 72 hours after surgery

Secondary outcomes

1

Quality of Recovery (QoR-15K) Score

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.

Time frame
Preoperatively and on postoperative days 1, 2, and 3
2

Postoperative Nausea and Vomiting Severity

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).

Time frame
24, 48, and 72 hours after surgery
3

Postoperative Pain Score

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.

Time frame
24, 48, and 72 hours after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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