Effect of Ketamine on Postoperative Clinical Outcomes - Full Text View

Purpose

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.

Condition	Intervention	Phase
Colorectal Surgery	Drug: Placebo Drug: Ketamine high-dose Drug: Ketamine low-dose	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Intraoperative Ketamine Administration in Colorectal Surgery: Effect on Postoperative Clinical Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Constipation Nausea and Vomiting

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Estimated Enrollment:	102
Study Start Date:	May 2011
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365195

Locations

United States, California
Cedars Sinai Medical center
Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

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

More Information

No publications provided

Responsible Party:	Roya Yumul, M.D.,PhD., Residency program director, Department of anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT01365195 History of Changes
Other Study ID Numbers:	Pro00024533
Study First Received:	June 1, 2011
Last Updated:	February 14, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:

opioid
Fentanyl
Anesthetic adjuvant
Pain management

Perioperative outcomes
Constipation
Ileus
Colorectal

Additional relevant MeSH terms:

Adjuvants, Anesthesia
Ketamine
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013