Effect of Ketamine on Postoperative Clinical Outcomes

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

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

ClinicalTrials.gov Identifier:

NCT01365195

First received: June 1, 2011

Last updated: February 14, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 1, 2011

Last Updated Date

February 14, 2012

Start Date ^ICMJE

May 2011

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Opioid consumption obtained from the recorded data [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) Post discharge use of opioid consumption (data obtained from the follow up questionnaires approximately one week after surgery).

And from the next postoperative visit (one month) after surgery.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01365195 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Postoperative pain using a Verbal Rating Scale [ Time Frame: one month ] [ Designated as safety issue: No ]
Postoperative will be measured at PACU, one week after surgery and at the next postoperative vist (one month) after surgery.
Nausea and vomiting will be measured with follow up [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU, one week after surgery and at the next postoperative vist (one month) after surgery.
Constipation (Ileus) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
at PACU, one week after surgery and at the next postoperative vist (one month) after surgery.

Original Secondary Outcome Measures ^ICMJE

Postoperative pain using a Verbal Rating Scale [ Time Frame: one month ] [ Designated as safety issue: No ]
Postoperative will be measured at PACU, one week after surgery and at the next postoperative vist (one month) after surgery.
Nausea and vomiting will be measured with follow up [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) and a questionnaires at PACU, one week after surgery at PACU, one week, and at the next postoperative vist (one month) after surgery.
Constipation (Ileus) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
at PACU and one week after surgery and at the next postoperative vist (one month) after surgery.
Constipation (Ileus) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
at PACU, one week, and at the next postoperative vist (one month) after surgery.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Ketamine on Postoperative Clinical Outcomes

Official Title ^ICMJE

Intraoperative Ketamine Administration in Colorectal Surgery: Effect on Postoperative Clinical Outcomes

Brief Summary

The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management and on the later recovery after surgery in patients undergoing colorectal surgery.

Adjuvant is a drug that has few or no pharmacological effects by itself, but may increase the effectiveness or strength of other drugs when given at the same time.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Colorectal Surgery

Intervention ^ICMJE

Drug: Placebo
Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate
Drug: Ketamine high-dose
Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
Drug: Ketamine low-dose
Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min

Study Arm (s)

Placebo Comparator: Control
Loading and Infusion:

Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate

Intervention: Drug: Placebo
Active Comparator: Ketamine low-dose
Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min

Intervention: Drug: Ketamine low-dose
Active Comparator: Ketamine high-dose
Loading: 1 mg/Kg Infusion: 10 mcg/kg/min

Intervention: Drug: Ketamine high-dose

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

102

Estimated Completion Date

March 2012

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria

Patients scheduled to undergo small and/or large partial bowel resection via laparotomy or laparoscopy
Willingness and ability to sign an informed consent document
No allergies to anesthetic or analgesic medications
18 - 80 years of age
ASA Class I - III adults of either sex

Exclusion Criteria

Inability to comprehend the pain assessment tools
Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
Patients with clinically-significant heart disease including arrhythmias and significant hypertension, brain aneurysms, prior history of CVA, or chronic renal insufficiency
Prior abdominal surgery
History of abdominal carcinomatosis
History of radiation enteritis;
Patients with history of hepatic, renal, cardiac failure, organ transplant, or diabetes
Patients with seizures
Morbid obesity (body mass index >40)
Pregnant or lactating women
Subjects with a history of alcohol or drug abuse within the past 3 months
Any other conditions or use of any medication which may interfere with the conduct of the study
Prophylactic NGT use
Individuals with significant manic disorders including: schizophrenia, or bipolar disorder or psychosis
Individuals with asthma and/or thyroid diseases

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01365195

Other Study ID Numbers ^ICMJE

Pro00024533

Has Data Monitoring Committee

Responsible Party

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

Study Sponsor ^ICMJE

Cedars-Sinai Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Roya Yumul, MD PhD	Cedars-Sinai Medical Center
Study Director:	Roya Yumul, MD., PhD	Cedars-Sinai Medical Center

Information Provided By

Cedars-Sinai Medical Center

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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