Trial Outcomes & Findings for Effect of Lidocaine and Esmolol to Improve the Quality of Recovery (NCT NCT01114997)
NCT ID: NCT01114997
Last Updated: 2016-11-03
Results Overview
Outcome had a duration of one day at post-anesthesia care unit (PACU) Postoperative pain measured using a Verbal Rating Scale (VRS) Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
1 day
Results posted on
2016-11-03
Participant Flow
Participant milestones
| Measure |
Lidocaine
Pre-Induction:
Lidocaine Loading: 1 mg/kg Post- Induction:Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)
|
Esmolol
Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min
|
Lidocaine + Esmolol (Combo)
Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
11
|
|
Overall Study
COMPLETED
|
11
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Lidocaine and Esmolol to Improve the Quality of Recovery
Baseline characteristics by cohort
| Measure |
Lidocaine
n=11 Participants
Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)
|
Esmolol
n=10 Participants
Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min
|
Lidocaine + Esmolol (Combo)
n=11 Participants
Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-Induction (Maintenance Infusion):
Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 8 • n=5 Participants
|
44 years
STANDARD_DEVIATION 3 • n=7 Participants
|
38 years
STANDARD_DEVIATION 10 • n=5 Participants
|
41 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
32 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 dayOutcome had a duration of one day at post-anesthesia care unit (PACU) Postoperative pain measured using a Verbal Rating Scale (VRS) Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain.
Outcome measures
| Measure |
Lidocaine
n=11 Participants
Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)
|
Esmolol
n=10 Participants
Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min
|
Lidocaine + Esmolol (Combo)
n=11 Participants
Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)
|
|---|---|---|---|
|
Post Operative Pain
|
4 Score on a scale
Standard Deviation 4
|
2 Score on a scale
Standard Deviation 2
|
4 Score on a scale
Standard Deviation 3
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Experience of pain at home
Highest Post Operative pain one month after surgery, using a verbal rating score from 0 (no pain) to 10 (highest level of pain). Patient received a post-operative follow-up call one month after surgery.
Outcome measures
| Measure |
Lidocaine
n=11 Participants
Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)
|
Esmolol
n=10 Participants
Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min
|
Lidocaine + Esmolol (Combo)
n=11 Participants
Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)
|
|---|---|---|---|
|
Number of Participants With Post Operative Pain One Month After Surgery
|
10 participants
|
8 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Opioid: Hydromorphone
Postoperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)
Outcome measures
| Measure |
Lidocaine
n=11 Participants
Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)
|
Esmolol
n=10 Participants
Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min
|
Lidocaine + Esmolol (Combo)
n=11 Participants
Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)
|
|---|---|---|---|
|
Opioid Consumption Obtained From the Recorded Data
|
1.5 mg
Standard Deviation 1
|
1 mg
Standard Deviation 0.8
|
1.5 mg
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 1dayPostoperative nausea using a Verbal Rating Scale Outcomes measured at the first day after surgery
Outcome measures
| Measure |
Lidocaine
n=11 Participants
Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)
|
Esmolol
n=10 Participants
Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min
|
Lidocaine + Esmolol (Combo)
n=11 Participants
Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)
|
|---|---|---|---|
|
Number of Participants With Postoperative Nausea One Day After Surgery
|
3 participants
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 1 monthDescription: return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities)
Outcome measures
| Measure |
Lidocaine
n=11 Participants
Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)
|
Esmolol
n=10 Participants
Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min
|
Lidocaine + Esmolol (Combo)
n=11 Participants
Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)
|
|---|---|---|---|
|
Return to Normal Activities of Daily Living Using Follow up Questionnaires
|
10 participants
|
8 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 1 monthPatient satisfaction using a verbal rating scale from 0 to 10 0= Not satisfied 10= Excellent
Outcome measures
| Measure |
Lidocaine
n=11 Participants
Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)
|
Esmolol
n=10 Participants
Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min
|
Lidocaine + Esmolol (Combo)
n=11 Participants
Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)
|
|---|---|---|---|
|
Patient Satisfaction
|
9.4 Score on a scale
Standard Deviation 0.8
|
9.2 Score on a scale
Standard Deviation 1
|
8.3 Score on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 1 dayOutcome measures
| Measure |
Lidocaine
n=11 Participants
Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)
|
Esmolol
n=10 Participants
Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min
|
Lidocaine + Esmolol (Combo)
n=11 Participants
Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)
|
|---|---|---|---|
|
Post-anesthesia Care Unit (PACU) Stay
|
236 Minutes
Standard Deviation 147
|
116 Minutes
Standard Deviation 38
|
214 Minutes
Standard Deviation 125
|
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
Lidocaine + Esmolol (Combo)
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