Trial Outcomes & Findings for Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain (NCT NCT04356352)
NCT ID: NCT04356352
Last Updated: 2024-09-19
Results Overview
pain scoring system previously used by studies looking at various remedies to decrease Propofol injection pain - 0-10 with 0=no pain up to 10=worst pain imaginable
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
33 participants
Primary outcome timeframe
following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Lidocaine
1 mg/kg lidocaine to a max of 100 mg
Lidocaine: 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Esmolol
0.5 mg/kg esmolol to a max of 50 mg
Esmolol: 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Placebo
Saline water
Placebo: saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
7
|
|
Overall Study
COMPLETED
|
11
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
Reasons for withdrawal
| Measure |
Lidocaine
1 mg/kg lidocaine to a max of 100 mg
Lidocaine: 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Esmolol
0.5 mg/kg esmolol to a max of 50 mg
Esmolol: 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Placebo
Saline water
Placebo: saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
|---|---|---|---|
|
Overall Study
PIV in location that was excluded, surgery cancelled
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
3
|
1
|
Baseline Characteristics
PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
Baseline characteristics by cohort
| Measure |
Lidocaine
n=13 Participants
1 mg/kg lidocaine to a max of 100 mg
Lidocaine: 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Esmolol
n=13 Participants
0.5 mg/kg esmolol to a max of 50 mg
Esmolol: 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Placebo
n=7 Participants
Saline water
Placebo: saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 10.21 • n=13 Participants
|
44.9 years
STANDARD_DEVIATION 14.05 • n=13 Participants
|
48.57 years
STANDARD_DEVIATION 10.76 • n=7 Participants
|
47.39 years
STANDARD_DEVIATION 12.14 • n=33 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=11 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
5 Participants
n=10 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
3 Participants
n=6 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
17 Participants
n=27 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
|
Sex: Female, Male
Male
|
2 Participants
n=11 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
5 Participants
n=10 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
3 Participants
n=6 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
10 Participants
n=27 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
0 Participants
n=10 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
0 Participants
n=6 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
0 Participants
n=27 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
0 Participants
n=10 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
0 Participants
n=6 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
0 Participants
n=27 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
1 Participants
n=10 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
0 Participants
n=6 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
1 Participants
n=27 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=11 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
3 Participants
n=10 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
0 Participants
n=6 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
4 Participants
n=27 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
|
Race (NIH/OMB)
White
|
10 Participants
n=11 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
0 Participants
n=10 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
5 Participants
n=6 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
15 Participants
n=27 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
5 Participants
n=10 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
0 Participants
n=6 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
5 Participants
n=27 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
1 Participants
n=10 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
1 Participants
n=6 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
2 Participants
n=27 Participants • PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used
|
|
Region of Enrollment
United States
|
13 participants
n=13 Participants
|
13 participants
n=13 Participants
|
7 participants
n=7 Participants
|
33 participants
n=33 Participants
|
PRIMARY outcome
Timeframe: following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full inductionpain scoring system previously used by studies looking at various remedies to decrease Propofol injection pain - 0-10 with 0=no pain up to 10=worst pain imaginable
Outcome measures
| Measure |
Lidocaine
n=11 Participants
1 mg/kg lidocaine to a max of 100 mg
Lidocaine: 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Esmolol
n=10 Participants
0.5 mg/kg esmolol to a max of 50 mg
Esmolol: 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Placebo
n=6 Participants
Saline water
Placebo: saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
|---|---|---|---|
|
Patient Pain Score
|
0.45 score on a scale
Standard Deviation 0.66
|
0.5 score on a scale
Standard Deviation 1.02
|
1.83 score on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: heart rate is measured each minute for the first 10 minutes following inductionheart rate is measured as numbers on a scale with normal 60-100
Outcome measures
| Measure |
Lidocaine
n=11 Participants
1 mg/kg lidocaine to a max of 100 mg
Lidocaine: 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Esmolol
n=10 Participants
0.5 mg/kg esmolol to a max of 50 mg
Esmolol: 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Placebo
n=6 Participants
Saline water
Placebo: saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
|---|---|---|---|
|
Heart Rate
Minute 2
|
72.6 beats per minute
Standard Deviation 12.2
|
81 beats per minute
Standard Deviation 14.25
|
82 beats per minute
Standard Deviation 11.15
|
|
Heart Rate
Minute 3
|
72.4 beats per minute
Standard Deviation 14.18
|
82 beats per minute
Standard Deviation 17.46
|
77.2 beats per minute
Standard Deviation 11.33
|
|
Heart Rate
Minute 4
|
76.9 beats per minute
Standard Deviation 13.37
|
78.4 beats per minute
Standard Deviation 13.14
|
79 beats per minute
Standard Deviation 11.5
|
|
Heart Rate
Minute 5
|
76.8 beats per minute
Standard Deviation 16.99
|
91.7 beats per minute
Standard Deviation 26.54
|
83.3 beats per minute
Standard Deviation 10.89
|
|
Heart Rate
Minute 6
|
77.4 beats per minute
Standard Deviation 15.62
|
84 beats per minute
Standard Deviation 10.92
|
86 beats per minute
Standard Deviation 10.13
|
|
Heart Rate
Minute 7
|
83.3 beats per minute
Standard Deviation 24.25
|
89.5 beats per minute
Standard Deviation 12.41
|
84.3 beats per minute
Standard Deviation 11.76
|
|
Heart Rate
Minute 8
|
75.5 beats per minute
Standard Deviation 13.43
|
83.4 beats per minute
Standard Deviation 13.8
|
80.5 beats per minute
Standard Deviation 10.75
|
|
Heart Rate
Minute 9
|
73.6 beats per minute
Standard Deviation 15.46
|
85.2 beats per minute
Standard Deviation 8.98
|
80.8 beats per minute
Standard Deviation 8.3
|
|
Heart Rate
Minute 10
|
72.18 beats per minute
Standard Deviation 17.02
|
80.2 beats per minute
Standard Deviation 12.59
|
83.7 beats per minute
Standard Deviation 21.05
|
SECONDARY outcome
Timeframe: Systolic Blood Pressure is measured each minute for the first 10 minutes following inductionblood pressure measured in mmHg
Outcome measures
| Measure |
Lidocaine
n=11 Participants
1 mg/kg lidocaine to a max of 100 mg
Lidocaine: 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Esmolol
n=10 Participants
0.5 mg/kg esmolol to a max of 50 mg
Esmolol: 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Placebo
n=6 Participants
Saline water
Placebo: saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
|---|---|---|---|
|
Systolic Blood Pressure
Minute 2
|
122.7 mm Hg (millimeters of mercury)
Standard Deviation 18.15
|
126 mm Hg (millimeters of mercury)
Standard Deviation 26.45
|
147.2 mm Hg (millimeters of mercury)
Standard Deviation 33.45
|
|
Systolic Blood Pressure
Minute 3
|
116.1 mm Hg (millimeters of mercury)
Standard Deviation 22.77
|
114 mm Hg (millimeters of mercury)
Standard Deviation 23.6
|
153.3 mm Hg (millimeters of mercury)
Standard Deviation 31.78
|
|
Systolic Blood Pressure
Minute 4
|
121.6 mm Hg (millimeters of mercury)
Standard Deviation 12.19
|
112 mm Hg (millimeters of mercury)
Standard Deviation 20.52
|
134.4 mm Hg (millimeters of mercury)
Standard Deviation 17.94
|
|
Systolic Blood Pressure
Minute 5
|
115.4 mm Hg (millimeters of mercury)
Standard Deviation 14.45
|
110.5 mm Hg (millimeters of mercury)
Standard Deviation 18.59
|
123.8 mm Hg (millimeters of mercury)
Standard Deviation 21.47
|
|
Systolic Blood Pressure
Minute 6
|
117.9 mm Hg (millimeters of mercury)
Standard Deviation 10.31
|
138.6 mm Hg (millimeters of mercury)
Standard Deviation 29.79
|
136.5 mm Hg (millimeters of mercury)
Standard Deviation 52.49
|
|
Systolic Blood Pressure
Minute 7
|
121.2 mm Hg (millimeters of mercury)
Standard Deviation 20.79
|
140.9 mm Hg (millimeters of mercury)
Standard Deviation 37.29
|
128.8 mm Hg (millimeters of mercury)
Standard Deviation 37.33
|
|
Systolic Blood Pressure
Minute 8
|
113.8 mm Hg (millimeters of mercury)
Standard Deviation 15.52
|
127.1 mm Hg (millimeters of mercury)
Standard Deviation 27.54
|
137 mm Hg (millimeters of mercury)
Standard Deviation 43.08
|
|
Systolic Blood Pressure
Minute 9
|
116.8 mm Hg (millimeters of mercury)
Standard Deviation 6.94
|
122.4 mm Hg (millimeters of mercury)
Standard Deviation 26.09
|
126 mm Hg (millimeters of mercury)
Standard Deviation 29.81
|
|
Systolic Blood Pressure
Minute 10
|
108 mm Hg (millimeters of mercury)
Standard Deviation 12.17
|
117 mm Hg (millimeters of mercury)
Standard Deviation 18.42
|
128.4 mm Hg (millimeters of mercury)
Standard Deviation 30.88
|
SECONDARY outcome
Timeframe: Oxygen saturation measured each minute for the first 10 minutes following inductionoxygen saturation is measured on a percentage, with normal range \>90%
Outcome measures
| Measure |
Lidocaine
n=11 Participants
1 mg/kg lidocaine to a max of 100 mg
Lidocaine: 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Esmolol
n=10 Participants
0.5 mg/kg esmolol to a max of 50 mg
Esmolol: 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
Placebo
n=6 Participants
Saline water
Placebo: saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
|
|---|---|---|---|
|
Oxygen Saturation Percentage
Minute 2
|
99.6 percentage
Standard Deviation 0.64
|
99.9 percentage
Standard Deviation 0.3
|
99.8 percentage
Standard Deviation 0.37
|
|
Oxygen Saturation Percentage
Minute 3
|
99.6 percentage
Standard Deviation 0.64
|
99.89 percentage
Standard Deviation 0.31
|
99.8 percentage
Standard Deviation 0.37
|
|
Oxygen Saturation Percentage
Minute 4
|
99.5 percentage
Standard Deviation 0.66
|
99.9 percentage
Standard Deviation 0.3
|
99.8 percentage
Standard Deviation 0.37
|
|
Oxygen Saturation Percentage
Minute 5
|
99.2 percentage
Standard Deviation 1.19
|
99.9 percentage
Standard Deviation 0.3
|
99.8 percentage
Standard Deviation 0.37
|
|
Oxygen Saturation Percentage
Minute 6
|
99.2 percentage
Standard Deviation 1.19
|
99.89 percentage
Standard Deviation 0.31
|
99.2 percentage
Standard Deviation 0.9
|
|
Oxygen Saturation Percentage
Minute 7
|
99.2 percentage
Standard Deviation 1.19
|
99.7 percentage
Standard Deviation 0.46
|
99.3 percentage
Standard Deviation 0.47
|
|
Oxygen Saturation Percentage
Minute 8
|
98.8 percentage
Standard Deviation 1.47
|
99.6 percentage
Standard Deviation 0.66
|
99 percentage
Standard Deviation 1.16
|
|
Oxygen Saturation Percentage
Minute 9
|
99.2 percentage
Standard Deviation 1.19
|
99.9 percentage
Standard Deviation 0.31
|
99.5 percentage
Standard Deviation 0.76
|
|
Oxygen Saturation Percentage
Minute 10
|
99.3 percentage
Standard Deviation 1.14
|
99.7 percentage
Standard Deviation 0.64
|
99.3 percentage
Standard Deviation 0.94
|
Adverse Events
Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Esmolol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Michael Norton, MD
Wake Forest University Health Sciences
Phone: 336-716-8791
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place