Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil

Not Applicable

Completed

• Conditions: Laryngismus
• Interventions: Drug: Control; Drug: Remifentanil 1; Drug: Remifentanil 2

• Registration Number: NCT01456299
• Lead Sponsor: Gachon University Gil Medical Center

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2014-02-23
• Results First Submitted QC: 2014-02-23
• Results First Posted: 2014-04-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-24
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	The control group, which received an infusion of normal saline.
Remifentanil 1	Remifentanil 1	"Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml.
Remifentanil 2	Remifentanil 2	"Remifentanil 2": "The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml.

Primary Outcome Measures

Name	Time	Method
LMA Insertion Condition	at that time on LMA insertion only	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

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

Trial Locations

Locations (1)

Ajou University School of Medicine; 🇰🇷 Suwon, Korea, Republic of