Effect of Ketamine on Postoperative Clinical Outcomes

Colorectal Surgery Clinical Trial

Official title:

Intraoperative Ketamine Administration in Colorectal Surgery: Effect on Postoperative Clinical Outcomes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01365195
• Other study ID #: Pro00024533
• Status: Terminated
• Phase: Phase 4
• Start date: May 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2022
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Cedars Sinai Medical center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	one day
Secondary	Participants With Nausea and Vomiting at PACU	Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.	1 day