Effect of Ketamine on Postoperative Clinical Outcomes

• ClinicalTrials.gov Identifier: NCT01365195
• Recruitment Status: Terminated
• First Posted: June 3, 2011
• Results First Posted: March 2, 2022
• Last Update Posted: March 2, 2022
• Sponsor: Cedars-Sinai Medical Center
• Information provided by (Responsible Party): Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center

Tracking Information

• First Submitted Date: June 1, 2011
• First Posted Date: June 3, 2011
• Results First Submitted Date: January 17, 2022
• Results First Posted Date: March 2, 2022
• Last Update Posted Date: March 2, 2022
• Study Start Date: May 2011
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 9, 2022)

Number of Participants With Opioid Consumption [ Time Frame: 1 day ]

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

Original Primary Outcome Measures (submitted: June 1, 2011)

Opioid consumption obtained from the recorded data [ Time Frame: 1 month ]

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.

Current Secondary Outcome Measures (submitted: February 9, 2022)

• Postoperative Pain [ Time Frame: one day ]
  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.
• Participants With Nausea and Vomiting at PACU [ Time Frame: 1 day ]
  Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.

Original Secondary Outcome Measures (submitted: June 1, 2011)

• Postoperative pain using a Verbal Rating Scale [ Time Frame: one month ]
  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 ]
  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 ]
  at PACU and one week after surgery and at the next postoperative vist (one month) after surgery.
• Constipation (Ileus) [ Time Frame: 1 month ]
  at PACU, one week, and at the next postoperative vist (one month) after surgery.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Ketamine on Postoperative Clinical Outcomes
• Official Title: 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.
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Colorectal Surgery

Intervention

• Drug: Placebo
  Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate
  Other Name: Saline Solution
• 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 Arms

• Placebo Comparator: Control

  Loading and Infusion:

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

  Interventions:

  • Drug: Ketamine high-dose
  • Drug: Ketamine low-dose
• Active Comparator: Ketamine low-dose
  Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min
  Interventions:

  • Drug: Placebo
  • Drug: Ketamine high-dose
• Active Comparator: Ketamine high-dose
  Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
  Interventions:

  • Drug: Placebo
  • Drug: Ketamine low-dose

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 8, 2021): 21
• Original Estimated Enrollment (submitted: June 1, 2011): 102
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria

1. Patients scheduled to undergo small and/or large partial bowel resection via laparotomy or laparoscopy
2. Willingness and ability to sign an informed consent document
3. No allergies to anesthetic or analgesic medications
4. 18 - 80 years of age
5. American Society of Anesthesiologists (ASA) Class I - III adults of either sex

Exclusion Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01365195
• Other Study ID Numbers: Pro00024533
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
• Original Responsible Party: Roya Yumul MD, PhD, Cedars Sinai Medical Center
• Current Study Sponsor: Cedars-Sinai Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Cedars-Sinai Medical Center
• Verification Date: February 2022