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Not yet recruitingNCT07786155Updated Aug 26, 2026

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

An interventional study of Standard antiemetic and anesthetic protocol and Multimodal antiemetic and anesthetic protocol in Postoperative Nausea and Vomiting, sponsored by Seoul National University Hospital. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Postoperative Nausea and Vomiting
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Active comparator
    Control group

    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

  • Experimental
    Multimodal group

    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

  • 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.

05

What researchers measure

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

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Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07786155
Lead sponsor
Seoul National University Hospital
Responsible party
Shin Kyung Won, MD (Clinical Assistant Professor, Seoul National University Hospital) — Principal investigator
First posted
Aug 25, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2028 (estimated)
Completion
Sep 1, 2029 (estimated)
Last update
Aug 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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