Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil

NCT01456299 | Completed Results DMC

• 1 other identifier: AJIRB-MED-CT4-11-045
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngismus

Keywords

laryngeal mask airway; insertion; sevoflurane; remifentanil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frequency of Apnea

  baseline, 30sec after drug injection

Study Arms (3)

Control

PLACEBO COMPARATOR

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

Drug: Control

Remifentanil 1

ACTIVE COMPARATOR

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

Drug: Remifentanil 1

Remifentanil 2

ACTIVE COMPARATOR

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

Drug: Remifentanil 2

Interventions

Remifentanil 1 DRUG

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

Also known as: R1

Remifentanil 1

Control DRUG

The control group, which received an infusion of normal saline

Also known as: Placebo

Control

Remifentanil 2 DRUG

"Remifentanil 2": "The R2group, which received a target effect-site remifentanil concentration of 2 ng/ml.

Also known as: R2

Remifentanil 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

Sponsors & Collaborators

• Gachon University Gil Medical Center: lead

Study Sites (1)

Ajou University School of Medicine

Suwon, South Korea

Location

Related Publications (1)

• 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.

  PMID: 10364865 BACKGROUND

MeSH Terms

Conditions

Laryngismus

Condition Hierarchy (Ancestors)

Vocal Cord Dysfunction; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr.Kim
• Organization: Ajou University

kjyeop@ajou.ac.kr

82-32-460-3400

Study Officials

• Jong Yeop Kim, MD,PhD

  Ajou University School of Medicine

  STUDY DIRECTOR

• Jong Yeop Kim, MD, PhD

  Ajou Universiy School of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: October 20, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 15, 2019
• Results First Posted: April 4, 2014

Record last verified: 2019-02

Locations

KR (1)