Deep Extubation
Conditions
Brief summary
It has been reported that deep extubation can reduce cardiopulmonary complication against endotracheal tube extubation during emergence from general anesthesia. The investigators hypothesized that using desflurane with target controlled infusion of remifentanil is more effective than using desflurane alone during deep extubation. The purpose of this study is to evaluate the effect of remifentanil to prevent respiratory complication (etc. coughing) during emergence from general anesthesia.
Interventions
DRUGDesflurane with remifentanil
During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil
DRUGDesflurane
During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane
Sponsors
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 20-60 * patients undergoing elective surgery take more than an hour * Under general anesthesia using an LMA * ASA I,II
Exclusion criteria
* Patients on CNS depressants * Chronic opioid use * Corticosteroid * Pregnant patients * Full stomach * Morbidly obese (BMI \>35kg/m2) * Hepatitis B * Hepatitis C * Coronary artery disease * Liver disease * Renal disease * Seizure disorder Dropout criteria: * Need for reintubation due to breath holding * high ETCO2 during self ventilation (ETCO2\>50) * Surgeon or patient request
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Awakening Time | Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day. | The outcomes assessor will record from the time of extubation in operating room to the time of eye opening and mouth opening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate & Complication Rate Including Cough | assessing the success rate of deep extubation without complication and the occurrance of cough from the completion of surgery to 5minute after extubation. | We will assess the success rate of deep extubation without complication and the occurrence of cough during emergence from general anesthesia. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour. | The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain) |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desflurane Group 1.5 MAC desflurane until extubation
Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane | 25 |
| Desflurane With Remifentanil Group 1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil
Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil | 29 |
| Total | 54 |
Baseline characteristics
| Characteristic | Desflurane Group | Desflurane With Remifentanil Group | Total |
|---|---|---|---|
| Age, Continuous | 38.76 years STANDARD_DEVIATION 11.53 | 43.24 years STANDARD_DEVIATION 9.39 | 42.17 years STANDARD_DEVIATION 10.58 |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 11 Participants | 15 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 |
Outcome results
Primary
Awakening Time
The outcomes assessor will record from the time of extubation in operating room to the time of eye opening and mouth opening
Time frame: Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Desflurane Group | Awakening Time | 10 minutes |
| Desflurane With Remifentanil Group | Awakening Time | 7 minutes |
Secondary
Success Rate & Complication Rate Including Cough
We will assess the success rate of deep extubation without complication and the occurrence of cough during emergence from general anesthesia.
Time frame: assessing the success rate of deep extubation without complication and the occurrance of cough from the completion of surgery to 5minute after extubation.
Other Pre-specified
Postoperative Pain
The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)
Time frame: Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.