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| ID | Type | Description | Link |
|---|---|---|---|
| AJIRB-MED-CT4-11-045 | Registry Identifier | Ajou University IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | The control group, which received an infusion of normal saline. |
|
| Remifentanil 1 | Active Comparator | "Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml. |
|
| Remifentanil 2 | Active Comparator | "Remifentanil 2": "The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil 1 | Drug | "Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml. |
|
| 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 |
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jong Yeop Kim, MD,PhD | Ajou University School of Medicine | Study Director |
| Jong Yeop Kim, MD, PhD | Ajou Universiy School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University School of Medicine | Suwon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10364865 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Remifentanil 1 | The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml control: Patients received a normal saline only |
| FG001 | Control | The control group, which received an infusion of normal saline remifentanil 1: The patients received an infusion of remifentanil |
| FG002 | Remifentanil 2 | The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml remifentanil 2: Patients received no remifentanil |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
no differences in patient characteristics
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | The control group, which received an infusion of normal saline remifentanil 1: The patients received an infusion of remifentanil |
| BG001 | Remifentanil 1 | The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml control: Patients received a normal saline only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | at that time on LMA insertion only |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | The control group, which received an infusion of normal saline remifentanil 1: The patients received an infusion of remifentanil |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Kim | Ajou University | 82-32-460-3400 | kjyeop@ajou.ac.kr |
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| ID | Term |
|---|---|
| D007826 | Laryngismus |
| ID | Term |
|---|---|
| D064706 | Vocal Cord Dysfunction |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| Control | Drug | The control group, which received an infusion of normal saline |
|
|
| Remifentanil 2 | Drug | "Remifentanil 2": "The R2group, which received a target effect-site remifentanil concentration of 2 ng/ml. |
|
|
| BG002 | Remifentanil 2 | The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml remifentanil 2: Patients received no remifentanil |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml
control: Patients received a normal saline only
| OG002 | Remifentanil 2 | The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml remifentanil 2: Patients received no remifentanil |
|
|
| Secondary | Frequency of Apnea | If prolonged apnoea (> 30 s) developed, manual ventilation was assisted. And record the frequency of apnea on each group | Not Posted | baseline, 30sec after drug injection | Participants |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Remifentanil 1 | The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml control: Patients received a normal saline only | 0 | 34 | 0 | 34 |
| EG002 | Remifentanil 2 | The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml remifentanil 2: Patients received no remifentanil | 0 | 33 | 0 | 33 |
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| D010038 | Otorhinolaryngologic Diseases |