Trial Outcomes & Findings for Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery (NCT NCT02334059)
NCT ID: NCT02334059
Last Updated: 2020-06-01
Results Overview
Total hydromorphone use in 1st 24 hours post-operatively.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
During surgery and 24 hours post-op
Results posted on
2020-06-01
Participant Flow
Participant milestones
| Measure |
Ketamine
Ketamine: 0.5 mg/kg IV dose
Ketamine: Ketamine infusion plus placebo infusion of normal saline
Placebo: 2 placebo infusions
|
Ketamine Plus Magnesium
Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV
Ketamine plus magnesium: Ketamine plus magnesium infusion
|
Placebo
Placebo (normal saline)
Placebo: 2 placebo infusions
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
34
|
37
|
|
Overall Study
COMPLETED
|
37
|
34
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
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 |
Ketamine
n=37 Participants
Ketamine: 0.5 mg/kg IV dose
Ketamine: Ketamine infusion plus placebo infusion of normal saline
Placebo: 2 placebo infusions
|
Ketamine Plus Magnesium
n=34 Participants
Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV
Ketamine plus magnesium: Ketamine plus magnesium infusion
|
Placebo
n=37 Participants
Placebo (normal saline)
Placebo: 2 placebo infusions
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.68 years
STANDARD_DEVIATION 10.82 • n=37 Participants
|
44.15 years
STANDARD_DEVIATION 11.91 • n=34 Participants
|
39.97 years
STANDARD_DEVIATION 11.60 • n=37 Participants
|
42.56 years
STANDARD_DEVIATION 11.49 • n=108 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=37 Participants
|
29 Participants
n=34 Participants
|
29 Participants
n=37 Participants
|
85 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=37 Participants
|
5 Participants
n=34 Participants
|
8 Participants
n=37 Participants
|
23 Participants
n=108 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
37 participants
n=37 Participants
|
34 participants
n=34 Participants
|
37 participants
n=37 Participants
|
108 participants
n=108 Participants
|
|
BMI
|
47.48 kg/m2
STANDARD_DEVIATION 9.85 • n=37 Participants
|
45.57 kg/m2
STANDARD_DEVIATION 6.73 • n=34 Participants
|
47.37 kg/m2
STANDARD_DEVIATION 8.70 • n=37 Participants
|
46.84 kg/m2
STANDARD_DEVIATION 8.53 • n=108 Participants
|
|
Duration of Surgery
|
55.14 minutes
STANDARD_DEVIATION 8.25 • n=37 Participants
|
67.06 minutes
STANDARD_DEVIATION 15.12 • n=34 Participants
|
64.78 minutes
STANDARD_DEVIATION 13.23 • n=37 Participants
|
62.19 minutes
STANDARD_DEVIATION 13.39 • n=108 Participants
|
|
Pre-operative Pain Score
|
0.27 units on a scale
STANDARD_DEVIATION 1.04 • n=37 Participants
|
0.35 units on a scale
STANDARD_DEVIATION 0.95 • n=34 Participants
|
0.41 units on a scale
STANDARD_DEVIATION 1.3 • n=37 Participants
|
0.34 units on a scale
STANDARD_DEVIATION 1.1 • n=108 Participants
|
|
Pre-operative sedation score
|
2 units on a scale
STANDARD_DEVIATION 0.0 • n=37 Participants
|
1.97 units on a scale
STANDARD_DEVIATION 0.17 • n=34 Participants
|
2 units on a scale
STANDARD_DEVIATION 0.16 • n=37 Participants
|
2 units on a scale
STANDARD_DEVIATION 0.14 • n=108 Participants
|
|
Pre-operative PONV score
|
0.16 units on a scale
STANDARD_DEVIATION 0.50 • n=37 Participants
|
0.03 units on a scale
STANDARD_DEVIATION 0.17 • n=34 Participants
|
0.14 units on a scale
STANDARD_DEVIATION 0.54 • n=37 Participants
|
0.11 units on a scale
STANDARD_DEVIATION 0.44 • n=108 Participants
|
PRIMARY outcome
Timeframe: During surgery and 24 hours post-opTotal hydromorphone use in 1st 24 hours post-operatively.
Outcome measures
| Measure |
Ketamine
n=37 Participants
Ketamine: 0.5 mg/kg IV dose
Ketamine: Ketamine infusion plus placebo infusion of normal saline
Placebo: 2 placebo infusions
|
Ketamine Plus Magnesium
n=34 Participants
Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV
Ketamine plus magnesium: Ketamine plus magnesium infusion
|
Placebo
n=37 Participants
Placebo (normal saline)
Placebo: 2 placebo infusions
|
|---|---|---|---|
|
Total Hydromorphone Use
Intraoperative
|
161.5 mcg/Kg
Interval 119.6 to 203.3
|
159.6 mcg/Kg
Interval 109.4 to 209.7
|
195.9 mcg/Kg
Interval 149.6 to 242.3
|
|
Total Hydromorphone Use
PACU
|
41.9 mcg/Kg
Interval 20.5 to 63.3
|
47.8 mcg/Kg
Interval 24.6 to 71.0
|
47.3 mcg/Kg
Interval 24.1 to 70.5
|
SECONDARY outcome
Timeframe: Preoperatively and the 1st 24 hours post-opPain scores using VAS scale will be recorded pre-operatively, in the PACU, and every 4 hours until 24 hours post-op. The VAS is a 10 point scale, where 0 = no pain and 10 = the worst pain a subject has ever felt. The highest value 10, indicates an extreme self reported level of pain.
Outcome measures
| Measure |
Ketamine
n=37 Participants
Ketamine: 0.5 mg/kg IV dose
Ketamine: Ketamine infusion plus placebo infusion of normal saline
Placebo: 2 placebo infusions
|
Ketamine Plus Magnesium
n=34 Participants
Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV
Ketamine plus magnesium: Ketamine plus magnesium infusion
|
Placebo
n=37 Participants
Placebo (normal saline)
Placebo: 2 placebo infusions
|
|---|---|---|---|
|
Pain Scores Using Verbal Analogue Scale (VAS)
Prior to Surgery
|
0.41 units on a scale
Interval -0.03 to 0.84
|
0.35 units on a scale
Interval 0.02 to 0.68
|
0.27 units on a scale
Interval -0.08 to 0.62
|
|
Pain Scores Using Verbal Analogue Scale (VAS)
PACU
|
5.78 units on a scale
Interval 4.86 to 6.71
|
6.03 units on a scale
Interval 4.86 to 6.78
|
5.95 units on a scale
Interval 4.91 to 6.98
|
|
Pain Scores Using Verbal Analogue Scale (VAS)
4h after surgery
|
3.89 units on a scale
Interval 3.2 to 4.57
|
4.29 units on a scale
Interval 3.53 to 5.06
|
4.65 units on a scale
Interval 4.01 to 5.29
|
|
Pain Scores Using Verbal Analogue Scale (VAS)
8h after surgery
|
3.67 units on a scale
Interval 3.09 to 4.24
|
3.75 units on a scale
Interval 2.9 to 4.6
|
3.64 units on a scale
Interval 3.08 to 4.2
|
|
Pain Scores Using Verbal Analogue Scale (VAS)
12h after surgery
|
3.16 units on a scale
Interval 2.59 to 3.73
|
3.91 units on a scale
Interval 3.28 to 4.53
|
2.69 units on a scale
Interval 2.07 to 3.3
|
|
Pain Scores Using Verbal Analogue Scale (VAS)
16h after surgery
|
2.97 units on a scale
Interval 2.3 to 3.64
|
3.64 units on a scale
Interval 2.89 to 4.38
|
3.09 units on a scale
Interval 2.51 to 3.66
|
|
Pain Scores Using Verbal Analogue Scale (VAS)
20h after surgery
|
3.22 units on a scale
Interval 2.42 to 4.01
|
4.13 units on a scale
Interval 3.45 to 4.8
|
2.94 units on a scale
Interval 2.36 to 3.53
|
|
Pain Scores Using Verbal Analogue Scale (VAS)
24h after surgery
|
3.24 units on a scale
Interval 2.59 to 3.88
|
3.48 units on a scale
Interval 2.81 to 4.15
|
3.33 units on a scale
Interval 2.63 to 4.04
|
SECONDARY outcome
Timeframe: Intraoperative periodPopulation: Intraoperative period: Intraoperative Minimum Alveolar Concentration (MAC) of desflurane
The average MAC concentration of desflurane will be recorded during the intraoperative period. The Minimum Alveolar Concentration (MAC) of an inhaled anesthetic is the alveolar (or end-expiratory) concentration at which 50% of patients will not show a motor response to a standardized surgical incision.
Outcome measures
| Measure |
Ketamine
n=37 Participants
Ketamine: 0.5 mg/kg IV dose
Ketamine: Ketamine infusion plus placebo infusion of normal saline
Placebo: 2 placebo infusions
|
Ketamine Plus Magnesium
n=34 Participants
Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV
Ketamine plus magnesium: Ketamine plus magnesium infusion
|
Placebo
n=37 Participants
Placebo (normal saline)
Placebo: 2 placebo infusions
|
|---|---|---|---|
|
Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane
|
4.05 Minimal Alveolar Concentration (MAC)
Interval 3.74 to 4.35
|
4.02 Minimal Alveolar Concentration (MAC)
Interval 3.73 to 4.32
|
4.34 Minimal Alveolar Concentration (MAC)
Interval 3.98 to 4.71
|
Adverse Events
Ketamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketamine Plus Magnesium
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
Sanjib D Adhikary
Penn State Health Anesthesiology and Perioperative Medicine
Phone: 717-531-6597
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place