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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

In context

Postoperative Nausea and Vomiting

638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.

This study's planned enrollment of 72 is below the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.

Browse Postoperative Nausea and Vomiting studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 on preoperative Patients deemed unsuitable for participation by the investigator
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

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.

06

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.

Of 181 non-industry interventional studies with no phase under Postoperative Nausea and Vomiting, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 24 months is above that.

Counting every sponsor, half of 181 studies reached it within 13 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2026
First posted
Aug 25, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2028
CompletionEst.
Sep 1, 2029
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07786155
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
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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