Effect of Ketamine on Postoperative Clinical Outcomes

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ClinicalTrials.gov Identifier: NCT01365195

Recruitment Status : Terminated (recruitment failure)

First Posted : June 3, 2011

Results First Posted : March 2, 2022

Last Update Posted : March 2, 2022

Sponsor:

Information provided by (Responsible Party):

Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition	Colorectal Surgery
Interventions	Drug: Placebo Drug: Ketamine high-dose Drug: Ketamine low-dose
Enrollment	21

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Control	Ketamine Low-dose	Ketamine High-dose
Arm/Group Description	Loading and Infusion: ...	Loading: 0.5 mg/Kg Infusion: 5 mcg/...	Loading: 1 mg/Kg Infusion: 10 mcg/k...
Arm/Group Description	Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate	Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min	Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
Period Title: Overall Study
Started	6	8	7
Completed	6	8	7
Not Completed	0	0	0

Baseline Characteristics

Arm/Group Title		Control	Ketamine Low-dose	Ketamine High-dose	Total
Arm/Group Description		Loading and Infusion: ...	Loading: 0.5 mg/Kg Infusion: 5 mcg/...	Loading: 1 mg/Kg Infusion: 10 mcg/k...	Total of all reporting groups
Arm/Group Description		Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate	Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min	Loading: 1 mg/Kg Infusion: 10 mcg/kg/min	Total of all reporting groups
Overall Number of Baseline Participants		6	8	7	21
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	6 participants	8 participants	7 participants	21 participants
		40 (21)	46 (24)	58 (12)	48 (19)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	6 participants	8 participants	7 participants	21 participants
	Female	3 50.0%	6 75.0%	4 57.1%	13 61.9%
	Male	3 50.0%	2 25.0%	3 42.9%	8 38.1%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	6 participants	8 participants	7 participants	21 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	1 16.7%	1 12.5%	0 0.0%	2 9.5%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	1 14.3%	1 4.8%
	White	5 83.3%	7 87.5%	6 85.7%	18 85.7%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1.Primary Outcome


Title	Number of Participants With Opioid Consumption
Description	Perioperative use of opioid consumption at Post Anesthesia Care Unit (...
Description	Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Control	Ketamine Low-dose	Ketamine High-dose
Arm/Group Description:	Loading and Infusion: ...	Loading: 0.5 mg/Kg Infusion: 5 mcg/...	Loading: 1 mg/Kg Infusion: 10 mcg/k...
Arm/Group Description:	Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate	Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min	Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
Overall Number of Participants Analyzed	6	8	7
Measure Type: Number Unit of Measure: participants
	4	5	2

2.Secondary Outcome


Title	Postoperative Pain
Description	Postoperative pain was measured at PACU using a Verbal Rating Scale (V...
Description	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.
Time Frame	one day

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Control	Ketamine Low-dose	Ketamine High-dose
Arm/Group Description:	Loading and Infusion: ...	Loading: 0.5 mg/Kg Infusion: 5 mcg/...	Loading: 1 mg/Kg Infusion: 10 mcg/k...
Arm/Group Description:	Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate	Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min	Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
Overall Number of Participants Analyzed	6	8	7
Mean (Standard Deviation) Unit of Measure: Score on scale
	5.7 (4.6)	5.3 (4.6)	1 (2.2)

3.Secondary Outcome


Title	Participants With Nausea and Vomiting at PACU
Description	Postoperative nausea and vomiting at PACU Participants experiencing na...
Description	Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Control	Ketamine Low-dose	Ketamine High-dose
Arm/Group Description:	Loading and Infusion: ...	Loading: 0.5 mg/Kg Infusion: 5 mcg/...	Loading: 1 mg/Kg Infusion: 10 mcg/k...
Arm/Group Description:	Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate	Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min	Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
Overall Number of Participants Analyzed	6	8	7
Measure Type: Count of Participants Unit of Measure: Participants
	1 16.7%	3 37.5%	0 0.0%

Adverse Events

Time Frame	one month
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Control	Ketamine Low-dose	Ketamine High-dose
Arm/Group Description	Loading and Infusion: ...	Loading: 0.5 mg/Kg Infusion: 5 mcg/...	Loading: 1 mg/Kg Infusion: 10 mcg/k...
Arm/Group Description	Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate	Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min	Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
All-Cause Mortality
	Control	Ketamine Low-dose	Ketamine High-dose
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/6 (0.00%)	0/8 (0.00%)	0/7 (0.00%)
Serious Adverse Events Serious Adverse Events
	Control	Ketamine Low-dose	Ketamine High-dose
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/6 (0.00%)	0/8 (0.00%)	0/7 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Control	Ketamine Low-dose	Ketamine High-dose
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/6 (0.00%)	0/8 (0.00%)	0/7 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Research project Advisor
Organization:	Cedars Sinai Medical Center
Phone:	310-423-1682
EMail:	Ofelia.Elvir-Lazo@cshs.org

Layout table for additonal information

Responsible Party:	Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT01365195
Other Study ID Numbers:	Pro00024533
First Submitted:	June 1, 2011
First Posted:	June 3, 2011
Results First Submitted:	January 17, 2022
Results First Posted:	March 2, 2022
Last Update Posted:	March 2, 2022

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