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

• Sponsor: Ajou University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02809378
• Collaborator: HK inno.N Corporation (Industry)
• Enrollment: 150
• Location: 1
• Arms: 3
• Duration (Months): 10.6
• Patients Per Site Per Month: 14.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
PONV; Palonosetron; Anesthesia	Drug: Palonosetron; Drug: sevoflurane; Drug: remifentanil; Drug: pentothal sodium; Drug: propofol	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of Postoperative Nausea and Vomiting in the Women Patients Undergoing Thyroidectomy
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Apr 20, 2017
• Actual Study Completion Date: Apr 20, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. incidence of postoperative nausea and vomiting [24 hour postoperative]

Secondary Outcome Measures

1. incidence of postoperative nausea and vomiting [at immediate postoperative]

2. incidence of postoperative nausea and vomiting [6 hour postoperative]

3. incidence of postoperative nausea and vomiting [48 hour postoperative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou universiry hospital	Suwon	Gyeonggi-do	Korea, Republic of

Sponsors and Collaborators

• Ajou University School of Medicine
• HK inno.N Corporation

Investigators

• Principal Investigator: Dae Hee Kim, MD, Ajou University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DAE HEE KIM, Assistant Professor, Ajou University School of Medicine
• ClinicalTrials.gov Identifier: NCT02809378
• Other Study ID Numbers: MED-CT4-15-461
• First Posted: Jun 22, 2016
• Last Update Posted: Jul 21, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Remifentanil; Thiopental; Palonosetron; Propofol; Sevoflurane

Study Results

No Results Posted as of Jul 21, 2017