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Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil

Primary Purpose

Laryngismus

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remifentanil 1
Control
Remifentanil 2
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Laryngismus focused on measuring laryngeal mask airway, insertion, sevoflurane, remifentanil

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Adult patients, aged 18-60 with ASA physical status I or II, who were scheduled to minor elective surgery (< 1 h) were considered for the study

Exclusion Criteria:

- Exclusion criteria were allergies to the study drugs, a history of gastric reflux, a history of drug abuse, obesity (body mass index > 30 kg/m2) and suspected difficult airway

Sites / Locations

  • Ajou University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control

Remifentanil 1

Remifentanil 2

Arm Description

The control group, which received an infusion of normal saline.

"Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml.

"Remifentanil 2": "The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml.

Outcomes

Primary Outcome Measures

LMA Insertion Condition
The pre-determined effect-site concentration of remifentanil or normal saline was administered according to the patient's group.LMAs were size #3 for women and #4 for men.The conditions of the LMA insertion were graded on a three point scale using six variables (mouth opening, ease of LMA insertion, swallowing, coughing and gagging, head and body movements, laryngospasm). Each of these variables was rated as excellent, intermediate or poor.

Secondary Outcome Measures

Frequency of Apnea
If prolonged apnoea (> 30 s) developed, manual ventilation was assisted. And record the frequency of apnea on each group

Full Information

First Posted
October 19, 2011
Last Updated
February 24, 2019
Sponsor
Gachon University Gil Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01456299
Brief Title
Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil
Official Title
Target-controlled Infusion of Remifentanil for Laryngeal Mask Airway Insertion During Sevoflurane Induction in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to determine the most suitable effect-site concentration of remifentanil for the LMA insertion during inhaled induction with 8% sevoflurane in adults.
Detailed Description
For practical purposes, opioids with the ability to suppress upper airway reflexes have been used to facilitate insertion of the LMA during anaesthesia induction. To date, however, there have been no published reports addressing the use of remifentanil to facilitate LMA insertion during sevoflurane inhalation induction in adults. Therefore, the purpose of this study was to determine the most suitable effect-site concentration of remifentanil target-controlled infusion (TCI) for the LMA insertion during inhaled induction with 8% sevoflurane in adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngismus
Keywords
laryngeal mask airway, insertion, sevoflurane, remifentanil

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The control group, which received an infusion of normal saline.
Arm Title
Remifentanil 1
Arm Type
Active Comparator
Arm Description
"Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml.
Arm Title
Remifentanil 2
Arm Type
Active Comparator
Arm Description
"Remifentanil 2": "The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml.
Intervention Type
Drug
Intervention Name(s)
Remifentanil 1
Other Intervention Name(s)
R1
Intervention Description
"Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml.
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
Placebo
Intervention Description
The control group, which received an infusion of normal saline
Intervention Type
Drug
Intervention Name(s)
Remifentanil 2
Other Intervention Name(s)
R2
Intervention Description
"Remifentanil 2": "The R2group, which received a target effect-site remifentanil concentration of 2 ng/ml.
Primary Outcome Measure Information:
Title
LMA Insertion Condition
Description
The pre-determined effect-site concentration of remifentanil or normal saline was administered according to the patient's group.LMAs were size #3 for women and #4 for men.The conditions of the LMA insertion were graded on a three point scale using six variables (mouth opening, ease of LMA insertion, swallowing, coughing and gagging, head and body movements, laryngospasm). Each of these variables was rated as excellent, intermediate or poor.
Time Frame
at that time on LMA insertion only
Secondary Outcome Measure Information:
Title
Frequency of Apnea
Description
If prolonged apnoea (> 30 s) developed, manual ventilation was assisted. And record the frequency of apnea on each group
Time Frame
baseline, 30sec after drug injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Adult patients, aged 18-60 with ASA physical status I or II, who were scheduled to minor elective surgery (< 1 h) were considered for the study Exclusion Criteria: - Exclusion criteria were allergies to the study drugs, a history of gastric reflux, a history of drug abuse, obesity (body mass index > 30 kg/m2) and suspected difficult airway
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Yeop Kim, MD,PhD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jong Yeop Kim, MD, PhD
Organizational Affiliation
Ajou Universiy School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ajou University School of Medicine
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
10364865
Citation
Sivalingam P, Kandasamy R, Madhavan G, Dhakshinamoorthi P. Conditions for laryngeal mask insertion. A comparison of propofol versus sevoflurane with or without alfentanil. Anaesthesia. 1999 Mar;54(3):271-6. doi: 10.1046/j.1365-2044.1999.00663.x.
Results Reference
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Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil

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