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Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Female

Primary Purpose

Gallbladder Diseases

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sugammadex Injectable Product
Neostigmine Injectable Product
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gallbladder Diseases

Eligibility Criteria

19 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Experimental

Placebo Comparator

Arm Label

Sugammadex group

Neostigmine group

Arm Description

Sugammadex group receives the intravenous sugammadex of 2 mg/kg.

Neostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg.

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

First Posted
May 25, 2020
Last Updated
January 6, 2021
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04407078
Brief Title
Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Female
Official Title
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
January 6, 2021 (Actual)
Study Completion Date
January 6, 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 purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in female who are reversed with sugammadex or neostigmine.
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 Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugammadex group
Arm Type
Experimental
Arm Description
Sugammadex group receives the intravenous sugammadex of 2 mg/kg.
Arm Title
Neostigmine group
Arm Type
Placebo Comparator
Arm Description
Neostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg.
Intervention Type
Drug
Intervention Name(s)
Sugammadex Injectable Product
Intervention Description
Sugammadex of 2 mg/kg is injected.
Intervention Type
Drug
Intervention Name(s)
Neostigmine Injectable Product
Intervention Description
Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.
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 ene of surgery until endotracheal extubation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 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
State/Province
Gyeonggido
ZIP/Postal Code
16499
Country
Korea, Republic of

12. IPD Sharing Statement

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Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Female

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