Lung Cancer
Conditions
Keywords
one-lung ventilation, oxygenation
Brief summary
Which is more adequate general anesthetic agent, desflurane or propofol, for emergence and recovery time, and perioperative oxygenation in lung resection surgery?
Detailed description
The investigators plan to investigate the effects of desflurane on oxygenation (prevention of HPV) of OLV compare with propofol which is used in general anesthesia for lung resection. Transesophageal echocardiography (TEE) wiill be used to measure pulmonary blood flow during surgery visible and successively. To confirm the effect of HPV by measuring the change in pulmonary blood flow. The correlation between the blood oxygen concentration and attenuation of blood flow will be investigated.
Interventions
DRUGdesflurane
Desflurane group: this group of patients receives desflurane as the main anesthetic agent during one-lung anesthesia. Propofol group: this group of patients receives propofol as the main anesthetic agnet during on-lung anesthesia.
DRUGpropofol
Propofol group:this group of patients receives propofol as the main anesthetic agent during one-lung anesthesia.
Sponsors
Baxter Healthcare Corporation
Juntendo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients agree to participate in the study * Patients undergoing lung cancer surgery requiring one-lung ventilation. * American Society of Anesthesiologists Physical Status Class 1 or 2
Exclusion criteria
* Patients with any of the following will be excluded from lung cancer patients. * New York Heart Association Classification more than 2 * Respiratory dysfunction Vital Capacity or percent predicted Forced expiratory volume in one second is less than 50 % * Pulmonary hypertension with mean pulmonary arterial pressure more than 30 mmHg * Coagulation dysfunction * The administration of steroids and immunosuppressive agents within 3 months prior to surgery * Infection with active inflammation * Pneumonectomy patients * Cases of epidural anesthesia is contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation | prior to surgery to one-hour after extubation | Arterial blood gases are monitored.Pulmonary blood flow is measured using transesophageal echocardiogram. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rapidity of Emergence From Anesthesia | one minute after cessation of anethetic agents to one hour after extubation | Time to extubation and orientation, where the patient is. |
| Quality of Consiousness | after extubation | quality of consciousness will be assessed using Aldrete score |
| Postoperative Nausea and Vomiting | on the postoperative day 1 | degree of nausea and frequency of vomiting |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desflurane Desflurane group: this group of patients receives desflurane as the main anesthetic agent in addition to remifentanil infusion at 0.1\
0.3 mcg/kg/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured.
desflurane: Desflurane group: this group of patients receives desflurane as the main anesthetic agent during one-lung anesthesia.
Propofol group: this group of patients receives propofol as the main anesthetic agnet during on-lung anesthesia. | 40 |
| Propofol Propofol group: this group of patients receives propofol as the main anesthetic agent in addition to remifentanil infusion at the rate of 0.1\
0.3 mcg./g/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured.
propofol: Propofol group:this group of patients receives propofol as the main anesthetic agent during one-lung anesthesia. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Propofol | Total | Desflurane |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 10 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 70 Participants | 35 Participants |
| Age, Continuous | 63.2 years STANDARD_DEVIATION 6.6 | 63.8 years STANDARD_DEVIATION 8.5 | 64.5 years STANDARD_DEVIATION 9.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Japan | 40 participants | 80 participants | 40 participants |
| Sex: Female, Male Female | 16 Participants | 35 Participants | 19 Participants |
| Sex: Female, Male Male | 24 Participants | 45 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Oxygenation
Arterial blood gases are monitored.Pulmonary blood flow is measured using transesophageal echocardiogram.
Time frame: prior to surgery to one-hour after extubation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Desflurane | Oxygenation | Preoperative | 87.4 mmHg | Standard Deviation 12 |
| Desflurane | Oxygenation | DLV(post) | 429.9 mmHg | Standard Deviation 98.3 |
| Desflurane | Oxygenation | OLV(30min) | 137.7 mmHg | Standard Deviation 78.2 |
| Desflurane | Oxygenation | 5min after exT | 131.63 mmHg | Standard Deviation 44.2 |
| Desflurane | Oxygenation | DLV(pre) | 469.9 mmHg | Standard Deviation 79.8 |
| Desflurane | Oxygenation | 30min after exT | 125.71 mmHg | Standard Deviation 45.3 |
| Desflurane | Oxygenation | OLV(45min) | 140.7 mmHg | Standard Deviation 86.6 |
| Desflurane | Oxygenation | 60min after exT | 130.49 mmHg | Standard Deviation 45 |
| Desflurane | Oxygenation | OLV(15min) | 178.5 mmHg | Standard Deviation 95 |
| Propofol | Oxygenation | 60min after exT | 137.2 mmHg | Standard Deviation 36 |
| Propofol | Oxygenation | OLV(15min) | 214.7 mmHg | Standard Deviation 114.2 |
| Propofol | Oxygenation | Preoperative | 85.7 mmHg | Standard Deviation 11.3 |
| Propofol | Oxygenation | DLV(pre) | 483.8 mmHg | Standard Deviation 91.7 |
| Propofol | Oxygenation | OLV(30min) | 161.6 mmHg | Standard Deviation 95.4 |
| Propofol | Oxygenation | OLV(45min) | 171.57 mmHg | Standard Deviation 95.6 |
| Propofol | Oxygenation | DLV(post) | 427.49 mmHg | Standard Deviation 111.6 |
| Propofol | Oxygenation | 5min after exT | 134.88 mmHg | Standard Deviation 64 |
| Propofol | Oxygenation | 30min after exT | 125.65 mmHg | Standard Deviation 32.91 |
Secondary
Postoperative Nausea and Vomiting
degree of nausea and frequency of vomiting
Time frame: on the postoperative day 1
Population: the number of patients who encountered PONV for 24 hours after surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Desflurane | Postoperative Nausea and Vomiting | 15 Participants |
| Propofol | Postoperative Nausea and Vomiting | 10 Participants |
Secondary
Quality of Consiousness
quality of consciousness will be assessed using Aldrete score
Time frame: after extubation
Population: number of the patients who cannot achieve full consciousness in Aldlete score 5min after extubation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desflurane | Quality of Consiousness | 2 participants |
| Propofol | Quality of Consiousness | 0 participants |
Secondary
Rapidity of Emergence From Anesthesia
Time to extubation and orientation, where the patient is.
Time frame: one minute after cessation of anethetic agents to one hour after extubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desflurane | Rapidity of Emergence From Anesthesia | 252.3 seconds | Standard Deviation 156.3 |
| Propofol | Rapidity of Emergence From Anesthesia | 269.5 seconds | Standard Deviation 142.9 |