Effect of a Multimodal Antiemetic Protocol on Postoperative Nausea and Vomiting in Patients Undergoing Flap Surgery for Head and Neck Cancer
24. august 2026 opdateret af: Shin Kyung Won, MD, Seoul National University Hospital
Effect of a Multimodal Antiemetic Protocol on Postoperative Nausea and Vomiting in Patients Undergoing Flap Surgery for Head and Neck Cancer: A Prospective Randomized Controlled 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
72
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control group
Patients receive inhalational anesthesia with sevoflurane and remifentanil.
Dexamethasone 5 mg is administered intravenously 1 hour before the end of surgery.
|
Patients receive general anesthesia maintained with sevoflurane and remifentanil.
Dexamethasone 5 mg is administered intravenously 1 hour before the end of surgery.
|
|
Eksperimentel: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Episodes of Moderate-to-Severe Postoperative Nausea and Vomiting Requiring Rescue Antiemetics
Tidsramme: 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.
|
Within 72 hours after surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Nausea and Vomiting Severity
Tidsramme: 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).
|
24, 48, and 72 hours after surgery
|
|
Quality of Recovery (QoR-15K) Score
Tidsramme: 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.
|
Preoperatively and on postoperative days 1, 2, and 3
|
|
Postoperative Pain Score
Tidsramme: 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.
|
24, 48, and 72 hours after surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. september 2028
Studieafslutning (Anslået)
1. september 2029
Datoer for studieregistrering
Først indsendt
21. august 2026
Først indsendt, der opfyldte QC-kriterier
21. august 2026
Først opslået (Faktiske)
25. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2606-122-1756
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