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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809378
• Other study ID #: MED-CT4-15-461
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2016
• Last updated: July 18, 2017
• Start date: June 2016
• Est. completion date: April 20, 2017

Study information

• Verified date: July 2017
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 20, 2017
• Est. primary completion date: April 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia
• Palonosetron
• PONV
• Postoperative Nausea and Vomiting

Intervention

Drug:
• Palonosetron
newly developed 5-HT3 antagonists with long half life (48 hrs) intravenous administration prior to anesthesia induction
• sevoflurane
Inhalational anesthetics Halogenated.
• remifentanil
ultra-short acting opioid anesthetics
• pentothal sodium
intra-venous anesthetics for anesthesia induction
• propofol
intra-venous anesthetics for anesthesia induction and maintenance

Locations

Country	Name	City	State
Korea, Republic of	Ajou universiry hospital	Suwon	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Ajou University School of Medicine	CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postoperative nausea and vomiting		24 hour postoperative
Secondary	incidence of postoperative nausea and vomiting		at immediate postoperative
Secondary	incidence of postoperative nausea and vomiting		6 hour postoperative
Secondary	incidence of postoperative nausea and vomiting		48 hour postoperative