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

Ajou University School of Medicine

Status and phase: Completed; Phase 4

Conditions: PONV; Palonosetron; Anesthesia

Treatments: Drug: pentothal sodium; Drug: propofol; Drug: remifentanil; Drug: sevoflurane; Drug: Palonosetron

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02809378

MED-CT4-15-461

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Sevoflurane

Experimental group

Description:

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

Treatment:

Drug: sevoflurane

Drug: pentothal sodium

sevoflurane, remifentanil, and propofol

Experimental group

Description:

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

Treatment:

Drug: sevoflurane

Drug: propofol

Drug: remifentanil

Sevoflurane, remifentanil, propofol, and palonosetron

Experimental group

Description:

anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%), and palonosetron 75 ug administration prior to anesthesia induction.

Treatment:

Drug: sevoflurane

Drug: Palonosetron

Drug: propofol

Drug: remifentanil