changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery at Post Anesthesia Care Unit, 24 and 48 hours
The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital
Brief 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.
. 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.
Intervention / Treatment
-
Ketamine (DRUG)determining the effect of low dose sub anesthetic doze of ketamine and placaebo on post operative patients
Condition or Disease
- Post Operative Inflammatory Marker Levels
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Unknown status |
| Study results: | No Results Available |
| Age: | 18 Years to 70 Years |
| Enrollment: | 30 (ESTIMATED) |
| Funded by: | Other |
| Allocation: | Randomized |
Masking |
|
Clinical Trial Dates
| Start date: | Apr 01, 2011 | |
|---|---|---|
| Primary Completion: | May 01, 2011 | ESTIMATED |
| Completion Date: | Jun 01, 2011 | ESTIMATED |
| Study First Posted: | Apr 20, 2011 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Apr 19, 2011 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
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.
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.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 70 |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
* 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
Exclusion Criteria:
* 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
* 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
Primary Outcomes
Secondary Outcomes
-
changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery at PACU, 24 and 48 hours
More Details
| NCT Number: | NCT01339065 |
|---|---|
| Other IDs: | MUK CHS |
| Study URL: | https://clinicaltrials.gov/study/NCT01339065 |
Last updated: Sep 29, 2023