Trial Outcomes & Findings for Postoperative Consequences of Intraoperative NOL Titration (NCT NCT04679818)
NCT ID: NCT04679818
Last Updated: 2024-06-21
Results Overview
Pain scores are measured using a Verbal Response Scale (VRS) every 10 minutes in the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
72 participants
Primary outcome timeframe
At 10-minute intervals during the first 60 minutes after extubation.
Results posted on
2024-06-21
Participant Flow
Participant milestones
| Measure |
PMD-200 NOL Group
Clinicians will titrate fentanyl to keep PMD-200 Nociception level (NOL) under 25 - always using good clinical judgement for individual patients
PMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg actual body weight (ABW), up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends
|
Control Group
Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.
Routine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
37
|
|
Overall Study
COMPLETED
|
34
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Postoperative Consequences of Intraoperative NOL Titration
Baseline characteristics by cohort
| Measure |
PMD-200 NOL Group
n=35 Participants
Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients
PMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends
|
Control Group
n=37 Participants
Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.
Routine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 16 • n=5 Participants
|
54 years
STANDARD_DEVIATION 15 • n=7 Participants
|
56 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Height
|
171 cm
STANDARD_DEVIATION 11 • n=5 Participants
|
171 cm
STANDARD_DEVIATION 10 • n=7 Participants
|
171 cm
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Weight
|
78 kg
STANDARD_DEVIATION 19 • n=5 Participants
|
82 kg
STANDARD_DEVIATION 23 • n=7 Participants
|
80 kg
STANDARD_DEVIATION 21 • n=5 Participants
|
|
BMI
|
27 kg/m2
STANDARD_DEVIATION 5 • n=5 Participants
|
28 kg/m2
STANDARD_DEVIATION 6 • n=7 Participants
|
28 kg/m2
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Procedure type
Open
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Procedure type
Laparoscopy
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Surgery type
Colorectal
|
34 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Surgery type
Hernia
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Surgery type
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
ASA (American Society of Anesthesiologist) physical status
I (healthy)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
ASA (American Society of Anesthesiologist) physical status
II (mild systemic disease)
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
ASA (American Society of Anesthesiologist) physical status
III (severe systemic disease)
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Preoperative opioid use
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Preoperative antihypertension medication use
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 10-minute intervals during the first 60 minutes after extubation.Pain scores are measured using a Verbal Response Scale (VRS) every 10 minutes in the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.
Outcome measures
| Measure |
PMD-200 NOL Group
n=34 Participants
Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients
PMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends
|
Control Group
n=37 Participants
Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.
Routine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.
|
|---|---|---|
|
Pain Scores at 10-minute Intervals for the Initial Hour of Recovery
Time point 1
|
0 score on a scale
Interval 0.0 to 5.0
|
0 score on a scale
Interval 0.0 to 4.0
|
|
Pain Scores at 10-minute Intervals for the Initial Hour of Recovery
Time point 2
|
1.0 score on a scale
Interval 0.0 to 5.5
|
5.0 score on a scale
Interval 0.0 to 7.0
|
|
Pain Scores at 10-minute Intervals for the Initial Hour of Recovery
Time point 3
|
2.5 score on a scale
Interval 0.0 to 7.0
|
5.0 score on a scale
Interval 2.0 to 7.0
|
|
Pain Scores at 10-minute Intervals for the Initial Hour of Recovery
Time point 4
|
5.0 score on a scale
Interval 0.0 to 6.0
|
4.0 score on a scale
Interval 2.0 to 6.0
|
|
Pain Scores at 10-minute Intervals for the Initial Hour of Recovery
Time point 5
|
4.5 score on a scale
Interval 1.0 to 7.0
|
3.0 score on a scale
Interval 2.0 to 6.0
|
|
Pain Scores at 10-minute Intervals for the Initial Hour of Recovery
Time point 6
|
4.5 score on a scale
Interval 2.0 to 7.0
|
3.0 score on a scale
Interval 1.0 to 6.0
|
PRIMARY outcome
Timeframe: At 10-minute intervals during the first 30 minutes after extubation.Pain scores are measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.
Outcome measures
| Measure |
PMD-200 NOL Group
n=34 Participants
Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients
PMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends
|
Control Group
n=37 Participants
Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.
Routine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.
|
|---|---|---|
|
Pain Scores at 10-minute Intervals for the Initial 30 Minutes of Recovery
Time point 1
|
0 score on a scale
Interval 0.0 to 5.0
|
0 score on a scale
Interval 0.0 to 4.0
|
|
Pain Scores at 10-minute Intervals for the Initial 30 Minutes of Recovery
Time point 2
|
1.0 score on a scale
Interval 0.0 to 5.5
|
5.0 score on a scale
Interval 0.0 to 7.0
|
|
Pain Scores at 10-minute Intervals for the Initial 30 Minutes of Recovery
Time point 3
|
2.5 score on a scale
Interval 0.0 to 7.0
|
5.0 score on a scale
Interval 2.0 to 7.0
|
SECONDARY outcome
Timeframe: At 10-minute intervals during the first 60 minutes after extubation.Binary repeated-measures outcome of pain score will be defined as a pain score less than 5 (vs ≥5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.
Outcome measures
| Measure |
PMD-200 NOL Group
n=196 Measurements
Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients
PMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends
|
Control Group
n=217 Measurements
Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.
Routine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.
|
|---|---|---|
|
Number of Measurements With Pain Score Less Than 5 (vs ≥5) for Initial Hour of Recovery
|
112 measurements
|
130 measurements
|
SECONDARY outcome
Timeframe: At 10-minute intervals during the first 30 minutes after extubation.Binary repeated-measures outcome will be defined as a pain score less than 5 (vs ≥5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.
Outcome measures
| Measure |
PMD-200 NOL Group
n=95 Measurements
Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients
PMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends
|
Control Group
n=109 Measurements
Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.
Routine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.
|
|---|---|---|
|
Number of Measurements With Pain Score Less Than 5 (vs ≥5) for the Initial 30 Minutes of Recovery
|
63 measurements
|
61 measurements
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During the first 60 minutes after extubation.Number of analgesic rescue boluses in the first 60 minutes after extubation.
Outcome measures
| Measure |
PMD-200 NOL Group
n=34 Participants
Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients
PMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends
|
Control Group
n=37 Participants
Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.
Routine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.
|
|---|---|---|
|
Number of Analgesic Rescue Boluses
|
1 Number of boluses
Interval 0.0 to 2.0
|
2 Number of boluses
Interval 0.0 to 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 10-minute intervals during the first 60 minutes after extubation.Ramsay scores will be measured using Ramsay Sedation Scale every 10 minutes in the initial hour of recovery. Ramsay Sedation Scale: 1 = Patient is anxious and agitated or restless, or both; 2 = Patient is co-operative, oriented, and tranquil; 3 = Patient responds to commands only; 4 = Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; 5 = Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; 6 = Patient exhibits no response. Frequencies for each score were reported.
Outcome measures
| Measure |
PMD-200 NOL Group
n=203 Measurements
Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients
PMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends
|
Control Group
n=221 Measurements
Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.
Routine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.
|
|---|---|---|
|
Ramsay Scores During the First 60 Minutes
2 (Patient is co- operative, oriented, and tranquil)
|
92 Measurements
|
85 Measurements
|
|
Ramsay Scores During the First 60 Minutes
3 (Patient responds to commands only)
|
106 Measurements
|
132 Measurements
|
|
Ramsay Scores During the First 60 Minutes
4 (Patient exhibits brisk response to light glabellar tap or loud auditory stimulus)
|
5 Measurements
|
3 Measurements
|
|
Ramsay Scores During the First 60 Minutes
1 (Patient is anxious and agitated or restless)
|
0 Measurements
|
1 Measurements
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From discontinuation of sevoflurane anesthesia to extubation intraoperatively, assessed up to the timepoint of leaving operation room.Time to emergence from anesthesia is defined as minutes from discontinuation of sevoflurane anesthesia to extubation
Outcome measures
| Measure |
PMD-200 NOL Group
n=34 Participants
Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients
PMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends
|
Control Group
n=37 Participants
Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.
Routine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.
|
|---|---|---|
|
Treatment Effect on the Time to Emergence From Anesthesia.
|
18 minutes
Interval 16.0 to 22.0
|
20 minutes
Interval 18.0 to 22.0
|
Adverse Events
PMD-200 NOL Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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