Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil

Laryngismus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456299
• Other study ID #: AJIRB-MED-CT4-11-045
• Secondary ID: AJIRB-MED-CT4-11
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2019
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Laryngismus

Intervention

Drug:
• Remifentanil 1
"Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml.
• Control
The control group, which received an infusion of normal saline
• Remifentanil 2
"Remifentanil 2": "The R2group, which received a target effect-site remifentanil concentration of 2 ng/ml.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University School of Medicine	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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