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

Study Overview
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Brief Summary
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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.

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

Conditions
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PONV, Palonosetron, Anesthesia

Intervention / Treatment
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* Drug: Palonosetron
* Drug: sevoflurane
* Drug: remifentanil
* Drug: pentothal sodium
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |