Colorectal Surgery
Conditions
Keywords
opioid, Fentanyl, Anesthetic adjuvant, Pain management, Perioperative outcomes, Constipation, Ileus, Colorectal
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.
Interventions
DRUGKetamine low-dose
Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min
DRUGKetamine high-dose
Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
DRUGPlacebo
Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Opioid Consumption | 1 day | Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 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 | 1 day | Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Loading and Infusion:
Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate | 6 |
| Ketamine Low-dose Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min | 8 |
| Ketamine High-dose Loading: 1 mg/Kg Infusion: 10 mcg/kg/min | 7 |
| Total | 21 |
Baseline characteristics
| Characteristic | Ketamine Low-dose | Ketamine High-dose | Total | Control |
|---|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 24 | 58 years STANDARD_DEVIATION 12 | 48 years STANDARD_DEVIATION 19 | 40 years STANDARD_DEVIATION 21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 6 Participants | 18 Participants | 5 Participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 13 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 8 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 0 / 6 | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 | 0 / 7 |
Outcome results
Primary
Number of Participants With Opioid Consumption
Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Participants With Opioid Consumption | 4 participants |
| Ketamine Low-dose | Number of Participants With Opioid Consumption | 5 participants |
| Ketamine High-dose | Number of Participants With Opioid Consumption | 2 participants |
Secondary
Participants With Nausea and Vomiting at PACU
Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Participants With Nausea and Vomiting at PACU | 1 Participants |
| Ketamine Low-dose | Participants With Nausea and Vomiting at PACU | 3 Participants |
| Ketamine High-dose | Participants With Nausea and Vomiting at PACU | 0 Participants |
Secondary
Postoperative Pain
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.
Time frame: one day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Postoperative Pain | 5.7 Score on scale | Standard Deviation 4.6 |
| Ketamine Low-dose | Postoperative Pain | 5.3 Score on scale | Standard Deviation 4.6 |
| Ketamine High-dose | Postoperative Pain | 1 Score on scale | Standard Deviation 2.2 |