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Completed

NCT Number: NCT02809378

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

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.

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Key information

Conditions

PONV Anesthesia Nausea Palonosetron Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ajou universiry hospital

Suwon, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Palonosetron

Drug

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

Sevoflurane

Drug

Inhalational anesthetics Halogenated.

Remifentanil

Drug

ultra-short acting opioid anesthetics

pentothal sodium

Drug

intra-venous anesthetics for anesthesia induction

Propofol

Drug

intra-venous anesthetics for anesthesia induction and maintenance

Primary outcomes

  1. incidence of postoperative nausea and vomiting

    Time frame: 24 hour postoperative

Secondary outcomes

  1. incidence of postoperative nausea and vomiting

    Time frame: at immediate postoperative

  2. incidence of postoperative nausea and vomiting

    Time frame: 6 hour postoperative

  3. incidence of postoperative nausea and vomiting

    Time frame: 48 hour postoperative

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Collaborators

  • HK inno.N Corporation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 22, 2016
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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