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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Surgery	Drug: Placebo; Drug: Ketamine high-dose; Drug: Ketamine low-dose	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Intraoperative Ketamine Administration in Colorectal Surgery: Effect on Postoperative Clinical Outcomes
• Study Start Date: May 2011
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Control; 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
Active Comparator: Ketamine low-dose; Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min	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
Active Comparator: Ketamine high-dose; Loading: 1 mg/Kg Infusion: 10 mcg/kg/min	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 low-dose; Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

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

• Responsible Party: Roya Yumul, M.D.,PhD., Residency program director, Department of anesthesiology, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT01365195
• Other Study ID Numbers: Pro00024533
• First Posted: June 3, 2011
• Results First Posted: March 2, 2022
• Last Update Posted: March 2, 2022
• Last Verified: February 2022

Keywords provided by Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center:

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

Additional relevant MeSH terms:

Ketamine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action