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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02809378
Other study ID # MED-CT4-15-461
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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