Trial Outcomes & Findings for Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia (NCT NCT00901394)
NCT ID: NCT00901394
Last Updated: 2020-09-16
Results Overview
Difference between baseline (pre-operative) and peak postoperative (i.e., maximum of postoperative value obtained within 30 minutes after anesthesia end time and morning of post-operative day 1) tHcy concentration . Of note: there were no secondary outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
Immediately postoperatively and on postoperative day 1
Results posted on
2020-09-16
Participant Flow
63 patients were consented however only 59 were analyzed.
Participant milestones
| Measure |
B-vitamins Plus Nitrous Oxide
IV vitamin B12 (cyanocobalamin) 1 mg,
IV folic acid, 5 mg,
60% nitrous oxide
|
Nitrous Oxide Plus Placebo
60% nitrous oxide
Placebo: normal saline (no vitamins)
|
Nitrous Oxide-free Group Plus Placebo
No nitrous oxide during anesthesia (oxygen/nitrogen)
Placebo: normal saline
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
22
|
|
Overall Study
COMPLETED
|
20
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
B-vitamins Plus Nitrous Oxide
IV vitamin B12 (cyanocobalamin) 1 mg,
IV folic acid, 5 mg,
60% nitrous oxide
|
Nitrous Oxide Plus Placebo
60% nitrous oxide
Placebo: normal saline (no vitamins)
|
Nitrous Oxide-free Group Plus Placebo
No nitrous oxide during anesthesia (oxygen/nitrogen)
Placebo: normal saline
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
2
|
Baseline Characteristics
Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia
Baseline characteristics by cohort
| Measure |
B-vitamins Plus Nitrous Oxide
n=20 Participants
|
Nitrous Oxide Plus Placebo
n=19 Participants
|
Nitrous Oxide-free Group Plus Placebo
n=20 Participants
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 13 • n=5 Participants
|
40 years
STANDARD_DEVIATION 14 • n=7 Participants
|
42 years
STANDARD_DEVIATION 15 • n=5 Participants
|
41 years
STANDARD_DEVIATION 14 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
20 participants
n=5 Participants
|
59 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Immediately postoperatively and on postoperative day 1Difference between baseline (pre-operative) and peak postoperative (i.e., maximum of postoperative value obtained within 30 minutes after anesthesia end time and morning of post-operative day 1) tHcy concentration . Of note: there were no secondary outcomes.
Outcome measures
| Measure |
Treatment 1
n=20 Participants
B12-Folic acid, nitrous oxide
B12-Folic Acid, nitrous oxide: IV vitamin B12 (cyanocobalamin) 1 mg, single administration over 30 min.
IV folic acid, 5 mg, single administration over 30 min.
Both diluted in 250 ml normal saline.
Nitrous oxide (NO) and placebo: 60% nitrous oxide anesthesia plus saline
|
Treatment 2
n=19 Participants
Nitrous oxide (NO) and placebo
Nitrous oxide (NO) and placebo: 60% nitrous oxide anesthesia plus saline
Placebo: Saline
|
Control Group
n=20 Participants
oxygen nitrogen
Placebo: Saline
oxygen nitrogen: 60% air and oxygen mix.
|
|---|---|---|---|
|
Change in Plasma Total Homocysteine Concentration (tHcy)
|
1.9 mcmol/L
Interval 0.2 to 3.6
|
2.7 mcmol/L
Interval 0.6 to 4.8
|
0.5 mcmol/L
Interval -0.8 to 1.9
|
Adverse Events
B-vitamins Plus Nitrous Oxide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nitrous Oxide Plus Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Nitrous Oxide-free Group Plus Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
B-vitamins Plus Nitrous Oxide
n=20 participants at risk
|
Nitrous Oxide Plus Placebo
n=19 participants at risk
|
Nitrous Oxide-free Group Plus Placebo
n=20 participants at risk
|
|---|---|---|---|
|
Nervous system disorders
PONV
|
0.00%
0/20 • AEs were assessed only in the immediate study period (surgery to postoperative day 1)
|
10.5%
2/19 • AEs were assessed only in the immediate study period (surgery to postoperative day 1)
|
0.00%
0/20 • AEs were assessed only in the immediate study period (surgery to postoperative day 1)
|
|
Cardiac disorders
Postop. cardiac troponin elevation
|
0.00%
0/20 • AEs were assessed only in the immediate study period (surgery to postoperative day 1)
|
0.00%
0/19 • AEs were assessed only in the immediate study period (surgery to postoperative day 1)
|
5.0%
1/20 • AEs were assessed only in the immediate study period (surgery to postoperative day 1)
|
Additional Information
Principal Investigator
University of Chicago
Phone: 7737022544
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place