The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of PONV

NCT02809378 | Completed Phase 4

• 1 other identifier: MED-CT4-15-461
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of postoperative nausea and vomiting (PONV) after thyroidectomy have been shown to be relatively high compared other surgeries, with a reported incidence 65-75 %. PONV may increase patient discomfort, delay patient discharge, and increase the cost of patient care, the risk of postoperative bleeding which may potentially cause airway obstruction. It is reported that the maintenance of anesthesia with propofol-remifentanil or sevoflurane-propofol-remifentanil decreased the incidence of PONV compared sevoflurane alone, but failed to demonstrate the decreased incidence of PONV in 6-24 hr postoperative period in patients undergoing thyroidectomy. Administration of Palonosetron, newly developed 5-HT3 antagonists with long half life (48 hrs) may decrease the incidence of PONV particularly during this period. The purpose of this study was to evaluate and compare the incidence of PONV after thyroidectomy with three different anesthetic methods, sevoflurane or sevoflurane-propofol-remifentanil or sevoflurane-propofol-remifentanil-palonosetron in woman patients.

Conditions

PONV; Palonosetron; Anesthesia

Outcome Measures

Primary Outcomes (1)

• incidence of postoperative nausea and vomiting

  24 hour postoperative

Secondary Outcomes (3)

• incidence of postoperative nausea and vomiting

  at immediate postoperative

• incidence of postoperative nausea and vomiting

  6 hour postoperative

• incidence of postoperative nausea and vomiting

  48 hour postoperative

Study Arms (3)

Sevoflurane

EXPERIMENTAL

anesthesia induction with pentothal sodium (4-5 mg/kg), maintenance with sevoflurane(1.6-2.5 vol%)

Drug: sevoflurane; Drug: pentothal sodium

sevoflurane, remifentanil, and propofol

EXPERIMENTAL

anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%)

Drug: sevoflurane; Drug: remifentanil; Drug: propofol

Sevoflurane, remifentanil, propofol, and palonosetron

EXPERIMENTAL

anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%), and palonosetron 75 ug administration prior to anesthesia induction.

Drug: Palonosetron; Drug: sevoflurane; Drug: remifentanil; Drug: propofol

Interventions

Palonosetron DRUG

newly developed 5-HT3 antagonists with long half life (48 hrs) intravenous administration prior to anesthesia induction

Sevoflurane, remifentanil, propofol, and palonosetron

sevoflurane DRUG

Inhalational anesthetics Halogenated.

Sevoflurane; Sevoflurane, remifentanil, propofol, and palonosetron; sevoflurane, remifentanil, and propofol

remifentanil DRUG

ultra-short acting opioid anesthetics

Sevoflurane, remifentanil, propofol, and palonosetron; sevoflurane, remifentanil, and propofol

pentothal sodium DRUG

intra-venous anesthetics for anesthesia induction

Sevoflurane

propofol DRUG

intra-venous anesthetics for anesthesia induction and maintenance

Sevoflurane, remifentanil, propofol, and palonosetron; sevoflurane, remifentanil, and propofol

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients undergoing thyroidectomy euthyroid status American Society of Anesthesiology Physical status 1,2

You may not qualify if:

• Ideal body weight \>130% gastrointestinal disease prior administration of anti-emetics (24hr)

Sponsors & Collaborators

• Ajou University School of Medicine: lead
• HK inno.N Corporation: collaborator

Study Sites (1)

Ajou universiry hospital

Suwon, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Palonosetron; Sevoflurane; Remifentanil; Thiopental; Propofol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Thiobarbiturates; Barbiturates; Pyrimidinones; Pyrimidines; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Dae Hee Kim, MD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 22, 2016
• Study Start: June 1, 2016
• Primary Completion: April 20, 2017
• Study Completion: April 20, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)