Effect of Palonosetron on Remifentanil for Preventing Emergence Cough in Female

May 10, 2021 updated by: Ji Eun Kim, Ajou University School of Medicine

Effect of Palonosetron on Effect-site Concentration of Remifentanil for Preventing Emergence Cough During General Anesthesia in Female Patients Undergoing Laparoscopic Cholecystectomy

The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in female patients who receive the palonosetron or not.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Suwon, Korea, Republic of
        • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

  • BMI > 30 kg/m2, respiratory infection, uncontrolled hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Control group receives the intravenous normal saline 2 mL.
Drug: Normal saline injection
Normal saline 2 mL, intravenous injection
Experimental: Palonosetron group
Palonosetron group receives the intravenous palonosetron 1.5 mL (0.075 mg) + normal saline 0.5 mL.
Drug: Palonosetron Injection [Aloxi]
Palonosetron 1.5 mL (0.075 mg) + Normal saline 0.5 mL, intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
optimal Ce of remifentanil
Time Frame: From the end of surgery until the time of endotracheal extubation, about 20 minutes
Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia
From the end of surgery until the time of endotracheal extubation, about 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Actual)

March 19, 2021

Study Completion (Actual)

March 19, 2021

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 24, 2020

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-THE-20-174

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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