Back to resultsEffect of Palonosetron on Remifentanil for Preventing Emergence Cough in Female
Primary Purpose
Gallbladder Diseases
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Normal saline injection
Palonosetron Injection [Aloxi]
Sponsored by
About this trial
This is an interventional prevention trial for Gallbladder Diseases
Eligibility Criteria
Inclusion Criteria:
- Laparoscopic cholecystectomy under general anesthesia
Exclusion Criteria:
- BMI > 30 kg/m2, respiratory infection, uncontrolled hypertension
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Palonosetron group
Arm Description
Control group receives the intravenous normal saline 2 mL.
Palonosetron group receives the intravenous palonosetron 1.5 mL (0.075 mg) + normal saline 0.5 mL.
Outcomes
Primary Outcome Measures
optimal Ce of remifentanil
Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia
Secondary Outcome Measures
Full Information
NCT ID
NCT04563260
First Posted
September 15, 2020
Last Updated
May 10, 2021
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04563260
Brief Title
Effect of Palonosetron on Remifentanil for Preventing Emergence Cough in Female
Official Title
Effect of Palonosetron on Effect-site Concentration of Remifentanil for Preventing Emergence Cough During General Anesthesia in Female Patients Undergoing Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
March 19, 2021 (Actual)
Study Completion Date
March 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group receives the intravenous normal saline 2 mL.
Arm Title
Palonosetron group
Arm Type
Experimental
Arm Description
Palonosetron group receives the intravenous palonosetron 1.5 mL (0.075 mg) + normal saline 0.5 mL.
Intervention Type
Drug
Intervention Name(s)
Normal saline injection
Intervention Description
Normal saline 2 mL, intravenous injection
Intervention Type
Drug
Intervention Name(s)
Palonosetron Injection [Aloxi]
Intervention Description
Palonosetron 1.5 mL (0.075 mg) + Normal saline 0.5 mL, intravenous injection
Primary Outcome Measure Information:
Title
optimal Ce of remifentanil
Description
Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia
Time Frame
From the end of surgery until the time of endotracheal extubation, about 20 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Laparoscopic cholecystectomy under general anesthesia
Exclusion Criteria:
BMI > 30 kg/m2, respiratory infection, uncontrolled hypertension
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
City
Suwon
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Palonosetron on Remifentanil for Preventing Emergence Cough in Female
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