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

The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of Postoperative Nausea and Vomiting in the Women Patients Undergoing Thyroidectomy

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; PONV; Palonosetron
• Intervention / Treatment: Drug: sevoflurane; Drug: pentothal sodium; Drug: remifentanil; Drug: propofol; Drug: Palonosetron

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of
      • Ajou universiry hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sevoflurane; anesthesia induction with pentothal sodium (4-5 mg/kg), maintenance with sevoflurane(1.6-2.5 vol%)	Drug: sevoflurane; Inhalational anesthetics Halogenated.; Drug: pentothal sodium; intra-venous anesthetics for anesthesia induction
EXPERIMENTAL: sevoflurane, remifentanil, and propofol; anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%)	Drug: sevoflurane; Inhalational anesthetics Halogenated.; Drug: remifentanil; ultra-short acting opioid anesthetics; Drug: propofol; intra-venous anesthetics for anesthesia induction and maintenance
EXPERIMENTAL: Sevoflurane, remifentanil, propofol, and palonosetron; anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%), and palonosetron 75 ug administration prior to anesthesia induction.	Drug: sevoflurane; Inhalational anesthetics Halogenated.; Drug: remifentanil; ultra-short acting opioid anesthetics; Drug: propofol; intra-venous anesthetics for anesthesia induction and maintenance; Drug: Palonosetron; newly developed 5-HT3 antagonists with long half life (48 hrs) intravenous administration prior to anesthesia induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of postoperative nausea and vomiting	24 hour postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Collaborators: HK inno.N Corporation
• Investigators: Principal Investigator: Dae Hee Kim, MD, Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ACTUAL): April 20, 2017
• Study Completion (ACTUAL): April 20, 2017

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (ESTIMATE): June 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Antiemetics; Gastrointestinal Agents; Analgesics, Opioid; Narcotics; Serotonin Agents; Serotonin Antagonists; Hypnotics and Sedatives; GABA Modulators; GABA Agents; Anticonvulsants; Serotonin 5-HT3 Receptor Antagonists; Anesthetics, Inhalation; Remifentanil; Propofol; Palonosetron; Sevoflurane; Thiopental
• Other Study ID Numbers: MED-CT4-15-461

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO