Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil

Target-controlled Infusion of Remifentanil for Laryngeal Mask Airway Insertion During Sevoflurane Induction in Adults

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.

Study Overview

• Status: Completed
• Conditions: Laryngismus
• Intervention / Treatment: Drug: Control; Drug: Remifentanil 1; Drug: Remifentanil 2

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of
    • Ajou University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; The control group, which received an infusion of normal saline.	Drug: Control; The control group, which received an infusion of normal saline; Other Names: Placebo
Active Comparator: Remifentanil 1; "Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml.	Drug: Remifentanil 1; "Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml.; Other Names: R1
Active Comparator: Remifentanil 2; "Remifentanil 2": "The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml.	Drug: Remifentanil 2; "Remifentanil 2": "The R2group, which received a target effect-site remifentanil concentration of 2 ng/ml.; Other Names: R2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at that time on LMA insertion only

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Apnea	If prolonged apnoea (> 30 s) developed, manual ventilation was assisted. And record the frequency of apnea on each group	baseline, 30sec after drug injection

Collaborators and Investigators

• Sponsor: Gachon University Gil Medical Center
• Investigators: Study Director: Jong Yeop Kim, MD,PhD, Ajou University School of Medicine; Study Director: Jong Yeop Kim, MD, PhD, Ajou Universiy School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: October 19, 2011
• First Posted (Estimate): October 20, 2011

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: February 24, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: sevoflurane; insertion; remifentanil; laryngeal mask airway
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Laryngeal Diseases; Vocal Cord Dysfunction; Laryngismus; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: AJIRB-MED-CT4-11-045 (Registry Identifier: Ajou University IRB)

Drug and device information, study documents

• 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