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

NCT ID: NCT02809378

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-04-20

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.

Detailed Description

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Conditions

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PONV Palonosetron Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sevoflurane

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

Group Type EXPERIMENTAL

sevoflurane

Intervention Type DRUG

Inhalational anesthetics Halogenated.

pentothal sodium

Intervention Type DRUG

intra-venous anesthetics for anesthesia induction

sevoflurane, remifentanil, and propofol

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

Group Type EXPERIMENTAL

sevoflurane

Intervention Type DRUG

Inhalational anesthetics Halogenated.

remifentanil

Intervention Type DRUG

ultra-short acting opioid anesthetics

propofol

Intervention Type DRUG

intra-venous anesthetics for anesthesia induction and maintenance

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.

Group Type EXPERIMENTAL

Palonosetron

Intervention Type DRUG

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

sevoflurane

Intervention Type DRUG

Inhalational anesthetics Halogenated.

remifentanil

Intervention Type DRUG

ultra-short acting opioid anesthetics

propofol

Intervention Type DRUG

intra-venous anesthetics for anesthesia induction and maintenance

Interventions

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Palonosetron

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

Intervention Type DRUG

sevoflurane

Inhalational anesthetics Halogenated.

Intervention Type DRUG

remifentanil

ultra-short acting opioid anesthetics

Intervention Type DRUG

pentothal sodium

intra-venous anesthetics for anesthesia induction

Intervention Type DRUG

propofol

intra-venous anesthetics for anesthesia induction and maintenance

Intervention Type DRUG

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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role collaborator

Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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DAE HEE KIM

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dae Hee Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

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Ajou universiry hospital

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MED-CT4-15-461

Identifier Type: -

Identifier Source: org_study_id

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