Colorectal SurgeryPhase 4NCT01365195
Effect of Ketamine on Postoperative Clinical Outcomes
A Phase 4 study testing Ketamine high-dose and Ketamine low-dose in people with Colorectal Surgery, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Ketamine high-dose and Ketamine low-dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 18 - 80 years of age
- American Society of Anesthesiologists (ASA) Class I - III adults of either sex
Who cannot join
- 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;
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical center
Los Angeles, California, 90048
About this study
Official title: Intraoperative Ketamine Administration in Colorectal Surgery: Effect on Postoperative Clinical Outcomes
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.
Read the 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.
- Conditions
- Colorectal Surgery
- Being tested
- Placebo, Ketamine high-dose, Ketamine low-dose
- Keywords
- opioid, Fentanyl, Anesthetic adjuvant, Pain management, Perioperative outcomes, Constipation, Ileus, Colorectal
- Medical subject headings
- Agnosia, Constipation, Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Saline Solution
Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate
Ketamine high-doseDrug
Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
Ketamine low-doseDrug
Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Loading and Infusion:
Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate Receives: Drug: Ketamine high-dose; Drug: Ketamine low-dose |
| Ketamine low-dose | Active comparator | Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min Receives: Drug: Placebo; Drug: Ketamine high-dose |
| Ketamine high-dose | Active comparator | Loading: 1 mg/Kg Infusion: 10 mcg/kg/min Receives: Drug: Placebo; Drug: Ketamine low-dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Opioid Consumption
Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts
Measured: 1 day
Secondary outcomes (2)
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.
Measured: one day
Participants With Nausea and Vomiting at PACU
Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: recruitment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
- Investigators
- Roya Yumul, MD PhD, Principal investigator, Cedars-Sinai Medical CenterRoya Yumul, MD., PhD, Study director, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365195
- Sponsor's protocol ID
- Pro00024533
- Status last verified
- Feb 2022
- First submitted
- 1 Jun 2011
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Ketamine Administration in Colorectal Surgery: Effect on Postoperative Clinical Outcomes
- ClinicalTrials.gov ID
- NCT01365195
- Acronym / sponsor ID
- Pro00024533
- Conditions
- Colorectal Surgery
- Keywords
- opioid, Fentanyl, Anesthetic adjuvant, Pain management, Perioperative outcomes, Constipation, Ileus, Colorectal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment failure
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Posted 2 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Ketamine high-dose, Drug: Ketamine low-doseLoading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate |
| Ketamine low-dose | Active comparator | Drug: Placebo, Drug: Ketamine high-doseLoading: 0.5 mg/Kg Infusion: 5 mcg/kg/min |
| Ketamine high-dose | Active comparator | Drug: Placebo, Drug: Ketamine low-doseLoading: 1 mg/Kg Infusion: 10 mcg/kg/min |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 18 - 80 years of age
- American Society of Anesthesiologists (ASA) Class I - III adults of either sex
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Saline SolutionLoading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate | Drug | Ketamine high-dose, Ketamine low-dose |
| Ketamine high-doseLoading: 1 mg/Kg Infusion: 10 mcg/kg/min | Drug | Control, Ketamine low-dose |
| Ketamine low-doseLoading: 0.5 mg/Kg Infusion: 5 mcg/kg/min | Drug | Control, Ketamine high-dose |
Primary outcome
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
2 secondary outcomes
Postoperative Pain
Time frame: one day
Participants With Nausea and Vomiting at PACU
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roya Yumul, MD PhD principal investigator
Cedars-Sinai Medical Center
Roya Yumul, MD., PhD study director
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine high-dose and Ketamine low-dose in people with Colorectal Surgery, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Opioid Consumption (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.