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Effect of Ketamine on Postoperative Clinical Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Ketamine Low-dose Ketamine High-dose
Hide 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
Arm/Group Title Control Ketamine Low-dose Ketamine High-dose Total
Hide 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
Hide 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%
1.Primary Outcome
Title Number of Participants With Opioid Consumption
Hide Description Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Ketamine Low-dose Ketamine High-dose
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Ketamine Low-dose Ketamine High-dose
Hide 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
Hide Description Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Ketamine Low-dose Ketamine High-dose
Hide 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%
Time Frame one month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Ketamine Low-dose Ketamine High-dose
Hide 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%) 
Hide 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%) 
Hide 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%) 
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