Effect of Ketamine on Postoperative Clinical Outcomes

NCT01365195 | Terminated Phase 4 Results

• 1 other identifier: Pro00024533
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Surgery

Keywords

opioid; Fentanyl; Anesthetic adjuvant; Pain management; Perioperative outcomes; Constipation; Ileus; Colorectal

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Opioid Consumption

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

  1 day

Secondary Outcomes (2)

• Postoperative Pain

  one day

• Participants With Nausea and Vomiting at PACU

  1 day

Study Arms (3)

Control

PLACEBO COMPARATOR

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

Drug: Ketamine high-dose; Drug: Ketamine low-dose

Ketamine low-dose

ACTIVE COMPARATOR

Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min

Drug: Placebo; Drug: Ketamine high-dose

Ketamine high-dose

ACTIVE COMPARATOR

Loading: 1 mg/Kg Infusion: 10 mcg/kg/min

Drug: Placebo; Drug: Ketamine low-dose

Interventions

Placebo DRUG

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

Also known as: Saline Solution

Ketamine high-dose; Ketamine low-dose

Ketamine high-dose DRUG

Loading: 1 mg/Kg Infusion: 10 mcg/kg/min

Control; Ketamine low-dose

Ketamine low-dose DRUG

Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min

Control; Ketamine high-dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age
• American Society of Anesthesiologists (ASA) Class I - III adults of either sex

You may not qualify if:

• 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 cerebral vascular accident (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 Nasogastric Tube (NGT) use
• Individuals with significant manic disorders including: schizophrenia, or bipolar disorder or psychosis
• Individuals with asthma and/or thyroid diseases

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Agnosia; Constipation; Ileus

Interventions

Saline Solution; Ketamine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Research project Advisor
• Organization: Cedars Sinai Medical Center

Ofelia.Elvir-Lazo@cshs.org

310-423-1682

Study Officials

• Roya Yumul, MD PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Roya Yumul, MD., PhD

  Cedars-Sinai Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residency program director, Department of anesthesiology

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 3, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2022-02

Locations

US (1)