Trial Outcomes & Findings for Lidocaine and Ketamine in Abdominal Surgery (NCT NCT00721110)
NCT ID: NCT00721110
Last Updated: 2017-07-26
Results Overview
The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
postoperative day 2
Results posted on
2017-07-26
Participant Flow
This is a factorial study design with 64 patients randomized to 2 treatments each: lidocaine or placebo and ketamine or placebo. Each treatment was analyzed separately (i.e., lidocaine versus placebo and ketamine versus placebo separately). Though there are 4 distinct groups, the same 64 patients are in both lidocaine and ketamine analyses.
Participant milestones
| Measure |
Lidocaine/Ketamine
Intravenous Lidocaine + Ketamine Group
Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours.
Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours.
Medication doses were based on actual patient body weight to a maximum of 150% of ideal body weight based on the formula: 49 kg + 0.6 kg for each centimeter of height exceeding 152 centimeters
|
Lidocaine
Intravenous lidocaine Group - Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours.
|
Ketamine
Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
|
Placebo
A placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine or lidocaine not given
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
16
|
|
Overall Study
COMPLETED
|
15
|
16
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Lidocaine/Ketamine
Intravenous Lidocaine + Ketamine Group
Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours.
Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours.
Medication doses were based on actual patient body weight to a maximum of 150% of ideal body weight based on the formula: 49 kg + 0.6 kg for each centimeter of height exceeding 152 centimeters
|
Lidocaine
Intravenous lidocaine Group - Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours.
|
Ketamine
Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
|
Placebo
A placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine or lidocaine not given
|
|---|---|---|---|---|
|
Overall Study
Ultram use
|
1
|
0
|
0
|
0
|
|
Overall Study
vertical incision
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Lidocaine and Ketamine in Abdominal Surgery
Baseline characteristics by cohort
| Measure |
Lidocaine/Ketamine
n=15 Participants
Intravenous Lidocaine and Ketamine Group -
Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours. Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours. Medication doses were based on actual patient body weight to a maximum of 150% of ideal body weight based on the formula: 49 kg + 0.6 kg for each centimeter of height exceeding 152 centimeters.
|
Lidocaine
n=16 Participants
Intravenous lidocaine Group - A lidocaine is administered intravenously through out surgery and 24 hours after surgery.
Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours.
|
Ketamine
n=15 Participants
Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
|
Placebo
n=16 Participants
A placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine or Lidocaine not given
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 7 • n=5 Participants
|
46 years
STANDARD_DEVIATION 7 • n=7 Participants
|
46 years
STANDARD_DEVIATION 9 • n=5 Participants
|
47 years
STANDARD_DEVIATION 8 • n=4 Participants
|
46 years
STANDARD_DEVIATION 8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
62 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
American Society of Anesthesiologists Physical Status
A normal healthy patient
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
American Society of Anesthesiologists Physical Status
A patient with mild systemic disease
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
10 participants
n=5 Participants
|
15 participants
n=4 Participants
|
52 participants
n=21 Participants
|
|
American Society of Anesthesiologists Physical Status
A patient with severe systemic disease
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
8 participants
n=21 Participants
|
|
Body Mass Index
|
28 kg per meters squared
STANDARD_DEVIATION 6 • n=5 Participants
|
29 kg per meters squared
STANDARD_DEVIATION 6 • n=7 Participants
|
29 kg per meters squared
STANDARD_DEVIATION 10 • n=5 Participants
|
28 kg per meters squared
STANDARD_DEVIATION 6 • n=4 Participants
|
29 kg per meters squared
STANDARD_DEVIATION 7 • n=21 Participants
|
|
Preoperative 6-MWD
|
318 m
STANDARD_DEVIATION 47 • n=5 Participants
|
320 m
STANDARD_DEVIATION 44 • n=7 Participants
|
304 m
STANDARD_DEVIATION 41 • n=5 Participants
|
338 m
STANDARD_DEVIATION 52 • n=4 Participants
|
320 m
STANDARD_DEVIATION 47 • n=21 Participants
|
PRIMARY outcome
Timeframe: postoperative day 2The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.
Outcome measures
| Measure |
Lidocaine
n=31 Participants
Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.
|
Nonlidocaine
n=31 Participants
Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.
Placebo boluses and infusions will be substituted for the lidocaine
|
Ketamine
n=30 Participants
Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
|
Nonketamine
n=32 Participants
A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine not given
|
|---|---|---|---|---|
|
The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two
|
202 meters
Standard Deviation 66
|
202 meters
Standard Deviation 73
|
193 meters
Standard Deviation 77
|
210 meters
Standard Deviation 61
|
SECONDARY outcome
Timeframe: PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain.
Outcome measures
| Measure |
Lidocaine
n=31 Participants
Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.
|
Nonlidocaine
n=31 Participants
Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.
Placebo boluses and infusions will be substituted for the lidocaine
|
Ketamine
n=30 Participants
Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
|
Nonketamine
n=32 Participants
A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine not given
|
|---|---|---|---|---|
|
Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2
PACU admit
|
6.2 units on a scale
Standard Deviation 3.3
|
7.1 units on a scale
Standard Deviation 2.5
|
6.4 units on a scale
Standard Deviation 3.4
|
6.9 units on a scale
Standard Deviation 2.5
|
|
Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2
PACU discharge
|
4.0 units on a scale
Standard Deviation 2.3
|
4.9 units on a scale
Standard Deviation 1.9
|
4.6 units on a scale
Standard Deviation 2.4
|
4.3 units on a scale
Standard Deviation 1.9
|
|
Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2
POD 1
|
4.0 units on a scale
Standard Deviation 1.8
|
3.3 units on a scale
Standard Deviation 2.2
|
3.7 units on a scale
Standard Deviation 2.2
|
3.6 units on a scale
Standard Deviation 1.7
|
|
Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2
POD 2
|
3.1 units on a scale
Standard Deviation 1.7
|
2.9 units on a scale
Standard Deviation 1.9
|
3.1 units on a scale
Standard Deviation 2.1
|
2.8 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: intraoperative through postoperative day 2Outcome measures
| Measure |
Lidocaine
n=31 Participants
Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.
|
Nonlidocaine
n=31 Participants
Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.
Placebo boluses and infusions will be substituted for the lidocaine
|
Ketamine
n=30 Participants
Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
|
Nonketamine
n=32 Participants
A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine not given
|
|---|---|---|---|---|
|
Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2
intraoperative
|
20 milligram morphine sulfate equivalents
Interval 15.0 to 30.0
|
20 milligram morphine sulfate equivalents
Interval 19.0 to 30.0
|
20 milligram morphine sulfate equivalents
Interval 15.0 to 26.0
|
23 milligram morphine sulfate equivalents
Interval 20.0 to 30.0
|
|
Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2
postoperative care unit
|
20 milligram morphine sulfate equivalents
Interval 7.0 to 27.0
|
23 milligram morphine sulfate equivalents
Interval 18.0 to 27.0
|
20 milligram morphine sulfate equivalents
Interval 7.0 to 27.0
|
23 milligram morphine sulfate equivalents
Interval 19.0 to 27.0
|
|
Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2
postoperative day 1
|
23 milligram morphine sulfate equivalents
Interval 15.0 to 48.0
|
22 milligram morphine sulfate equivalents
Interval 13.0 to 50.0
|
21 milligram morphine sulfate equivalents
Interval 12.0 to 48.0
|
23 milligram morphine sulfate equivalents
Interval 17.0 to 47.0
|
|
Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2
postoperative day 2
|
10 milligram morphine sulfate equivalents
Interval 3.0 to 18.0
|
6 milligram morphine sulfate equivalents
Interval 2.0 to 15.0
|
9 milligram morphine sulfate equivalents
Interval 3.0 to 20.0
|
8 milligram morphine sulfate equivalents
Interval 3.0 to 14.0
|
SECONDARY outcome
Timeframe: 2 hours after surgery, on postoperative day 1Outcome measures
| Measure |
Lidocaine
n=31 Participants
Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.
|
Nonlidocaine
n=31 Participants
Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.
Placebo boluses and infusions will be substituted for the lidocaine
|
Ketamine
n=30 Participants
Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
|
Nonketamine
n=32 Participants
A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine not given
|
|---|---|---|---|---|
|
Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day
Nausea, PACU
|
32 percentage of participants
|
26 percentage of participants
|
30 percentage of participants
|
28 percentage of participants
|
|
Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day
Nausea, POD 1
|
55 percentage of participants
|
48 percentage of participants
|
53 percentage of participants
|
50 percentage of participants
|
|
Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day
Vomiting, PACU
|
6 percentage of participants
|
19 percentage of participants
|
10 percentage of participants
|
16 percentage of participants
|
|
Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day
Vomiting, POD 1
|
23 percentage of participants
|
16 percentage of participants
|
23 percentage of participants
|
16 percentage of participants
|
SECONDARY outcome
Timeframe: postoperative day 1Population: 11 patients had missing POD 1 fatigue scores (e.g., 11 for lidocaine vs. nonlidocaine and 11 for ketamine vs. nonketamine).
Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue.
Outcome measures
| Measure |
Lidocaine
n=26 Participants
Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.
|
Nonlidocaine
n=25 Participants
Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.
Placebo boluses and infusions will be substituted for the lidocaine
|
Ketamine
n=24 Participants
Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
|
Nonketamine
n=27 Participants
A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine not given
|
|---|---|---|---|---|
|
Verbal Response Fatigue Score on Postoperative Day 1
|
7.2 units on a scale
Standard Deviation 2.5
|
7.2 units on a scale
Standard Deviation 2.4
|
7.4 units on a scale
Standard Deviation 2.6
|
7.0 units on a scale
Standard Deviation 2.3
|
Adverse Events
Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 16 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 16 deaths
Ketamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 15 deaths
Ketamine + Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 15 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