Trial Outcomes & Findings for Ketamine Infusion and Hypoventilation (NCT NCT01535976)

Last Updated: 2014-04-01

Results Overview

Subjects receiving intraoperative ketamine in addition to propofol will demonstrate less hypoventilation during the surgical procedure.

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

8 hours

Results posted on

2014-04-01

Hospital based recruitment. From August 2011 to June 2012.

Participant milestones
Measure	Ketamine Infusion of ketamine Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case	Placebo .9 normal saline infusion Placebo : Placebo Comparator: Placebo .9 normal saline infusion
Overall Study STARTED	27	27
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	1	1

Withdrawal data not reported

Ketamine Infusion and Hypoventilation

Baseline characteristics by cohort
Measure	Ketamine n=27 Participants Infusion of ketamine Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case along with propofol 100 mcg/kg/min	Placebo n=27 Participants normal saline infusion Placebo : Placebo Comparator: Placebo normal saline infusion along with propofol 100 mcg/kg/min	Total n=54 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	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	48.4 years STANDARD_DEVIATION 7.67 • n=5 Participants	46.89 years STANDARD_DEVIATION 7.35 • n=7 Participants	47.65 years STANDARD_DEVIATION 7.55 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	27 participants n=7 Participants	54 participants n=5 Participants

Timeframe: 8 hours

Population: The median percentage of the sedation time with TCO2 \> 50 mmHg

Subjects receiving intraoperative ketamine in addition to propofol will demonstrate less hypoventilation during the surgical procedure.

Outcome measures
Measure	Ketamine n=26 Participants Infusion of ketamine Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case along with propofol 100 mcg/kg/min.	Placebo n=26 Participants normal saline infusion Placebo : Placebo Comparator: Placebo normal saline infusion along with propofol 100 mcg/kg/min
Intraoperative Hypoventilation	1.2 % time 95% Confidence Interval 95 • Interval 0.0 to 83.0	65 % time Interval 0.0 to 88.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Northwestern University

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