Trial Outcomes & Findings for Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea (NCT NCT03109418)
NCT ID: NCT03109418
Last Updated: 2019-12-19
Results Overview
Visual Analog Scale pain rating
TERMINATED
PHASE2/PHASE3
9 participants
up to 24 hours postoperatively
2019-12-19
Participant Flow
Three participants were excluded prior to randomization due to the following reasons: 1. The patient was experiencing on-going neurological issues and was therefore removed from the study prior to randomization. 2. The patient missed his/her own surgery date. 3. The patient ended up having outpatient surgery, and was therefore excluded.
Participant milestones
| Measure |
Control Group
OSA patients will receive standard inhaled anesthesia with normal saline infusion
Control: OSA patients receiving standard inhaled anesthesia combined with normal saline
|
Ketamine Group
OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.
Ketamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Control Group
n=2 Participants
OSA patients will receive standard inhaled anesthesia with normal saline infusion
Control: OSA patients receiving standard inhaled anesthesia combined with normal saline
|
Ketamine Group
n=3 Participants
OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.
Ketamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Males
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 hours postoperativelyPopulation: Study was terminated. Data was not collected.
Visual Analog Scale pain rating
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 24 hrs post-opPopulation: Participants were not analyzed due to study being terminated. Data was not collected.
Patients will rate their quality of anesthesia services
Outcome measures
Outcome data not reported
Adverse Events
Control Group
Ketamine Group
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