Trial Outcomes & Findings for Comparison of Emergence and Oxygenation During One-lung Ventilation With Desflurane and Propofol Anesthesia (NCT NCT02324283)
NCT ID: NCT02324283
Last Updated: 2024-04-05
Results Overview
Arterial blood gases are monitored.Pulmonary blood flow is measured using transesophageal echocardiogram.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
prior to surgery to one-hour after extubation
Results posted on
2024-04-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Desflurane
n=40 Participants
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.
|
Propofol
n=40 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=80 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=40 Participants
|
35 Participants
n=40 Participants
|
70 Participants
n=80 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=40 Participants
|
5 Participants
n=40 Participants
|
10 Participants
n=80 Participants
|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 9.7 • n=40 Participants
|
63.2 years
STANDARD_DEVIATION 6.6 • n=40 Participants
|
63.8 years
STANDARD_DEVIATION 8.5 • n=80 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=40 Participants
|
16 Participants
n=40 Participants
|
35 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=40 Participants
|
24 Participants
n=40 Participants
|
45 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
40 participants
n=40 Participants
|
40 participants
n=40 Participants
|
80 participants
n=80 Participants
|
PRIMARY outcome
Timeframe: prior to surgery to one-hour after extubationArterial blood gases are monitored.Pulmonary blood flow is measured using transesophageal echocardiogram.
Outcome measures
| Measure |
Desflurane
n=40 Participants
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.
|
Propofol
n=40 Participants
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.
|
|---|---|---|
|
Oxygenation
Preoperative
|
87.4 mmHg
Standard Deviation 12.0
|
85.7 mmHg
Standard Deviation 11.3
|
|
Oxygenation
DLV(pre)
|
469.9 mmHg
Standard Deviation 79.8
|
483.8 mmHg
Standard Deviation 91.7
|
|
Oxygenation
OLV(15min)
|
178.5 mmHg
Standard Deviation 95.0
|
214.7 mmHg
Standard Deviation 114.2
|
|
Oxygenation
OLV(30min)
|
137.7 mmHg
Standard Deviation 78.2
|
161.6 mmHg
Standard Deviation 95.4
|
|
Oxygenation
OLV(45min)
|
140.7 mmHg
Standard Deviation 86.6
|
171.57 mmHg
Standard Deviation 95.6
|
|
Oxygenation
DLV(post)
|
429.9 mmHg
Standard Deviation 98.3
|
427.49 mmHg
Standard Deviation 111.6
|
|
Oxygenation
5min after exT
|
131.63 mmHg
Standard Deviation 44.2
|
134.88 mmHg
Standard Deviation 64.0
|
|
Oxygenation
30min after exT
|
125.71 mmHg
Standard Deviation 45.3
|
125.65 mmHg
Standard Deviation 32.91
|
|
Oxygenation
60min after exT
|
130.49 mmHg
Standard Deviation 45.0
|
137.2 mmHg
Standard Deviation 36.0
|
SECONDARY outcome
Timeframe: one minute after cessation of anethetic agents to one hour after extubationTime to extubation and orientation, where the patient is.
Outcome measures
| Measure |
Desflurane
n=40 Participants
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.
|
Propofol
n=40 Participants
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.
|
|---|---|---|
|
Rapidity of Emergence From Anesthesia
|
252.3 seconds
Standard Deviation 156.3
|
269.5 seconds
Standard Deviation 142.9
|
SECONDARY outcome
Timeframe: after extubationPopulation: number of the patients who cannot achieve full consciousness in Aldlete score 5min after extubation
quality of consciousness will be assessed using Aldrete score
Outcome measures
| Measure |
Desflurane
n=40 Participants
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.
|
Propofol
n=40 Participants
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.
|
|---|---|---|
|
Quality of Consiousness
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: on the postoperative day 1Population: the number of patients who encountered PONV for 24 hours after surgery.
degree of nausea and frequency of vomiting
Outcome measures
| Measure |
Desflurane
n=40 Participants
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.
|
Propofol
n=40 Participants
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.
|
|---|---|---|
|
Postoperative Nausea and Vomiting
|
15 Participants
|
10 Participants
|
Adverse Events
Desflurane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Propofol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place