Trial Outcomes & Findings for Effect of Ketamine on Postoperative Clinical Outcomes (NCT NCT01365195)

NCT ID: NCT01365195

Last Updated: 2022-03-02

Results Overview

Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 21 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2022-03-02

Participant Flow

Participant milestones

Measure	Control Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate	Ketamine Low-dose Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min	Ketamine High-dose Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
Overall Study STARTED	6	8	7
Overall Study COMPLETED	6	8	7
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Ketamine on Postoperative Clinical Outcomes

Baseline characteristics by cohort

Measure	Control n=6 Participants Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate	Ketamine Low-dose n=8 Participants Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min	Ketamine High-dose n=7 Participants Loading: 1 mg/Kg Infusion: 10 mcg/kg/min	Total n=21 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 21 • n=5 Participants	46 years STANDARD_DEVIATION 24 • n=7 Participants	58 years STANDARD_DEVIATION 12 • n=5 Participants	48 years STANDARD_DEVIATION 19 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 day

Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts

Outcome measures

Measure	Control n=6 Participants Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate	Ketamine Low-dose n=8 Participants Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min	Ketamine High-dose n=7 Participants Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
Number of Participants With Opioid Consumption	4 participants	5 participants	2 participants

SECONDARY outcome

Timeframe: one day

Postoperative pain was measured at PACU using a Verbal Rating Scale (VRS) from 0 to 10 with 0 representing "no pain" and 10 "very much pain.

Outcome measures

Measure	Control n=6 Participants Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate	Ketamine Low-dose n=8 Participants Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min	Ketamine High-dose n=7 Participants Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
Postoperative Pain	5.7 Score on scale Standard Deviation 4.6	5.3 Score on scale Standard Deviation 4.6	1 Score on scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 1 day

Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.

Outcome measures

Measure	Control n=6 Participants Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate	Ketamine Low-dose n=8 Participants Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min	Ketamine High-dose n=7 Participants Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
Participants With Nausea and Vomiting at PACU	1 Participants	3 Participants	0 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ketamine Low-dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ketamine High-dose

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

Research project Advisor

Cedars Sinai Medical Center

Phone: 310-423-1682

Email: Ofelia.Elvir-Lazo@cshs.org

Results disclosure agreements

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