Post Operative Inflammatory Marker LevelsPhase 4NCT01339065
The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital
A Phase 4 study testing Ketamine in people with Post Operative Inflammatory Marker Levels, run by Makerere University at 1 site in Uganda.
Trial summary
. Null Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult patients undergoing elective surgery, in Mulago hospital, will not have a reduction effect on the levels of IL-6 \& IL-1β pro inflammatory markers by 48 hours. . Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Inflammatory Marker Levels
- What is being tested?
- Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUganda
- Study dates
- Apr 2011to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consented patients due for elective surgery
- Adult patients 18- 70 year old
- ASA I- ASA II scoring patients, who are normal patients or those with mild systemic illness
Who cannot join
- Emergency cases that will already have high levels of inflammatory markers secreted in their system by incision time e.g. road traffic accidents
- Patients with chronic / severe hypertension
- Febrile Patients (T >38°C)
- Persistently raised blood pressures above 140/90 for 2 consistent readings 15 minutes apart
- Patients with pheochromocytoma
- Spinal and local infiltration anaesthesia cases
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- Neuro surgery patients whom Ketamine is contra indicated
- Epilepsy patients
- ASA IIIE and above
- Patients receiving Aspirin prophylaxis
- Chronic inflammatory disease states such as hyperparathyroidism
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Mulago Hospital National Refferal, surgical wards
Kampala, +256
John M Kasumba, MBChB, MMed Anaesthesia- MUK, +25675625678 ext. +256701625678, drkasmaya@gmail.com
Tonny S Luggya, MBChB- MUK
About this study
Official title: The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital: A Randomized Clinical Trial
. Null Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult patients undergoing elective surgery, in Mulago hospital, will not have a reduction effect on the levels of IL-6 \& IL-1β pro inflammatory markers by 48 hours.
. Alternate Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult patients undergoing elective surgery, in Mulago hospital, will have a reduction effect on the levels of IL-6 \& IL-1β pro inflammatory markers by 48 hours.
Read the detailed description
RESEARCH QUESTION Can 0.5mg/kg of Ketamine given preoperatively have an effect on the levels of pro-inflammatory markers?
Primary specific Outcome: changes/deviations from baseline levels of IL- 6 pro-inflammatory markers of after surgery at PACU, 24 and 48 hours.
Secondary specific Outcome: changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery at PACU, 24 and 48 hours.
- Being tested
- Ketamine
- Keywords
- ketamine, inflammatory, pro inflammatory, pro inflammatory markers IL-6 and IL-1beta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
determining the effect of low dose sub anesthetic doze of ketamine and placaebo on post operative patients
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | will be given low sub-anesthetic doses of Ketamine 0.5mg/kg. Receives: Drug: Ketamine |
| Placebo | Placebo comparator | will get placebo treatment Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery
changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery at Post Anesthesia Care Unit, 24 and 48 hours
Measured: 48 hours
Secondary outcomes (1)
changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery
changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery at PACU, 24 and 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative Inflammatory Marker LevelsStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339065
- Sponsor's protocol ID
- MUK CHS
- Status last verified
- Apr 2011
- First submitted
- 19 Apr 2011
- Last updated
- 20 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Luggya TS, Roche T, Ssemogerere L, Kintu A, Kasumba JM, Kwizera A, Tindimwebwa JV. Effect of low-dose ketamine on post-operative serum IL-6 production among elective surgical patients: a randomized clinical trial. Afr Health Sci. 2017 Jun;17(2):500-507. doi: 10.4314/ahs.v17i2.25.
PubMed 29062346
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01339065
- Acronym / sponsor ID
- MUK CHS
- Keywords
- ketamine, inflammatory, pro inflammatory, pro inflammatory markers IL-6 and IL-1beta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
. Null Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult patients undergoing elective surgery, in Mulago hospital, will not have a reduction effect on the levels of IL-6 \& IL-1β pro inflammatory markers by 48 hours.
. Alternate Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult patients undergoing elective surgery, in Mulago hospital, will have a reduction effect on the levels of IL-6 \& IL-1β pro inflammatory markers by 48 hours.
Detailed description
RESEARCH QUESTION Can 0.5mg/kg of Ketamine given preoperatively have an effect on the levels of pro-inflammatory markers?
Primary specific Outcome: changes/deviations from baseline levels of IL- 6 pro-inflammatory markers of after surgery at PACU, 24 and 48 hours.
Secondary specific Outcome: changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery at PACU, 24 and 48 hours.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: Ketaminewill be given low sub-anesthetic doses of Ketamine 0.5mg/kg. |
| Placebo | Placebo comparator | Drug: Ketaminewill get placebo treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consented patients due for elective surgery
- Adult patients 18- 70 year old
- ASA I- ASA II scoring patients, who are normal patients or those with mild systemic illness
Key exclusion criteria (11 listed)
- Emergency cases that will already have high levels of inflammatory markers secreted in their system by incision time e.g. road traffic accidents
- Patients with chronic / severe hypertension
- Febrile Patients (T >38°C)
- Persistently raised blood pressures above 140/90 for 2 consistent readings 15 minutes apart
- Patients with pheochromocytoma
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 |
|---|---|---|
| Ketaminedetermining the effect of low dose sub anesthetic doze of ketamine and placaebo on post operative patients | Drug | Ketamine, Placebo |
Primary outcome
changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery
Time frame: 48 hours
changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery at Post Anesthesia Care Unit, 24 and 48 hours
1 secondary outcome
changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2011.
- Derived from this study: PubMed 29062346Luggya TS, Roche T, Ssemogerere L, Kintu A, Kasumba JM, Kwizera A, Tindimwebwa JV. Effect of low-dose ketamine on post-operative serum IL-6 production among elective surgical patients: a randomized clinical trial. Afr Health Sci. 2017 Jun;17(2):500-507. doi: 10.4314/ahs.v17i2.25.
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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.
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 in people with Post Operative Inflammatory Marker Levels, run by Makerere University at 1 site in Uganda.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Apr 2011. 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 Uganda. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01339065, which also lists 1 linked publication.
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 20 Apr 2011.