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Trial Outcomes & Findings for Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy (NCT NCT02452060)

NCT ID: NCT02452060

Last Updated: 2020-03-16

Results Overview

VAS Scores will be assessed on Day of Surgery (DOS), Post-op Day (POD) 1, 2 and 7. If patients have been discharged, coordinators will contact patient by home.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

90 participants

Primary outcome timeframe

Baseline (DOS) to 7 days (Post Op)

Results posted on

2020-03-16

Participant Flow

Participant milestones

Participant milestones
Measure
Treatment/Placebo
saline infusion Placebo Comparator: 0.4mg/kg infusion
Treatment
ketamine (0.4mg/kg) Ketamine: 0.4mg/kg infusion
Overall Study
STARTED
46
44
Overall Study
COMPLETED
46
44
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=46 Participants
Placebo Comparator: 0.4mg/kg saline infusion
Ketamine
n=44 Participants
Ketamine: 0.4mg/kg infusion
Total
n=90 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Age, Categorical
Between 18 and 65 years
46 Participants
n=39 Participants
44 Participants
n=41 Participants
90 Participants
n=35 Participants
Age, Categorical
>=65 years
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Sex: Female, Male
Female
29 Participants
n=39 Participants
33 Participants
n=41 Participants
62 Participants
n=35 Participants
Sex: Female, Male
Male
17 Participants
n=39 Participants
11 Participants
n=41 Participants
28 Participants
n=35 Participants
Race/Ethnicity, Customized
Black or African American
8 Participants
n=39 Participants
9 Participants
n=41 Participants
17 Participants
n=35 Participants
Race/Ethnicity, Customized
White
37 Participants
n=39 Participants
35 Participants
n=41 Participants
72 Participants
n=35 Participants
Race/Ethnicity, Customized
Asian
1 Participants
n=39 Participants
0 Participants
n=41 Participants
1 Participants
n=35 Participants
Region of Enrollment
United States
46 participants
n=39 Participants
44 participants
n=41 Participants
90 participants
n=35 Participants

PRIMARY outcome

Timeframe: Baseline (DOS) to 7 days (Post Op)

VAS Scores will be assessed on Day of Surgery (DOS), Post-op Day (POD) 1, 2 and 7. If patients have been discharged, coordinators will contact patient by home.

Outcome measures

Outcome measures
Measure
Treatment/Placebo
n=46 Participants
saline infusion Placebo Comparator: 0.4mg/kg infusion
Treatment
n=44 Participants
ketamine (0.4mg/kg) Ketamine: 0.4mg/kg infusion
Change in Pain Scores
1.45 score on a scale
Standard Deviation .23
1 score on a scale
Standard Deviation 0.18

SECONDARY outcome

Timeframe: 8 days

LOS will be recorded from medical record.

Outcome measures

Outcome measures
Measure
Treatment/Placebo
n=46 Participants
saline infusion Placebo Comparator: 0.4mg/kg infusion
Treatment
n=44 Participants
ketamine (0.4mg/kg) Ketamine: 0.4mg/kg infusion
Length of Stay During Hospitalization
1.3 Days
Interval 1.0 to 2.0
1.2 Days
Interval 1.0 to 1.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 Days

Length of stay and opioid usage will be recorded from electronic medical chart

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 days

recorded from medical chart

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 Days

Patient will be asked to record and report the time to OOB

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day

Spirometry use will be assessed by a study team member to determine whether the patient is meeting the goal set by the surgical team 4 hours after ketamine infusion.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day

changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-op,Day of Surgery through Post-op Day 8

Change in survey scores -- McGill's short form

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-op,Day of Surgery through Post-op Day 8

Change in survey scores for Becks Depression Index (BDI)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-op,Day of Surgery through Post-op Day 8

Change in scores for Quality of Recovery 15 - QoR15

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-op,Day of Surgery through Post-op Day 8

Change in scores for MADRS

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day

changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day

changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day

changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.

Outcome measures

Outcome data not reported

Adverse Events

Treatment/Placebo

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Treatment

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Treatment/Placebo
n=46 participants at risk
saline infusion Placebo Comparator: 0.4mg/kg infusion
Treatment
n=44 participants at risk
ketamine (0.4mg/kg) Ketamine: 0.4mg/kg infusion
General disorders
dizziness/lightheadedness
2.2%
1/46 • Number of events 1 • 1 Year
0
11.4%
5/44 • Number of events 5 • 1 Year
0
General disorders
nausea
4.3%
2/46 • Number of events 2 • 1 Year
0
4.5%
2/44 • Number of events 2 • 1 Year
0
General disorders
euphoria
4.3%
2/46 • Number of events 2 • 1 Year
0
0.00%
0/44 • 1 Year
0
Psychiatric disorders
visual hallucination
4.3%
2/46 • Number of events 2 • 1 Year
0
0.00%
0/44 • 1 Year
0
General disorders
headache
2.2%
1/46 • Number of events 1 • 1 Year
0
0.00%
0/44 • 1 Year
0
General disorders
Dysphoria
4.3%
2/46 • Number of events 2 • 1 Year
0
0.00%
0/44 • 1 Year
0

Additional Information

Jing Wang

NYU Langone Medical Center

Phone: 212-460-0176

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place