Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05950555 |
| Other study ID # |
B.30.2.ATA.0.01.00/23 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 30, 2021 |
| Est. completion date |
May 28, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary aim of this study was to compare the effects of dexmedetomidine and ketamine,
which are administered intravenously during surgery, on the levels of malondialdehyde, an
antioxidant, anti-inflammatory enzyme, heme oxygenase-1 enzyme levels and C-reactive protein
levels in patients who underwent lower extremity surgery under combined spinal epidural
anesthesia.
Description:
This study was planned as double-blind; The researcher who evaluated the patient and recorded
the data did not know which group the patient belonged to. The randomization sequence was
generated with a computerized random number generator and patients were assigned to 3 groups,
with 30 patients in each group.
The group to which the patient was included was listed in serially numbered sealed opaque
envelopes. Another investigator (not involved in this study and not blinded to group
assignment) administered CSEA to patients in a sitting position and opened the envelopes to
see which group the patient belonged to, and prepared and administered the drugs to be used
during anesthesia. An anesthetist, blinded to the group allocation, was responsible for
collecting the intraoperative data. During and after surgery, data were recorded by and by
this investigator. The blood of the patients was taken by the researcher who collected the
data and delivered to the researchers who made the biochemical analyzes of their blood and
blinded the groups. All surgeries were performed by the same surgical team and the same
anesthesia team.
Peripheral IV vascular access was established using a 16/18-gauge cannula on the day of the
operation. No premedication was applied to any patient before the operation. Before the
anesthesia procedure, the patients' age, weight, height, body mass indexes, american society
of anesthesiologists (ASA) physical status, systolic, diastolic and mean blood pressure
baseline values, heart rate and oxygen saturation levels were recorded.
CSEA was applied to all patients in the sitting position. Following skin sterilization and
local anesthetic infiltration (2% lidocaine), an 18-gauge Tuohy needle (CSEA, Braun,
Melsungen, Germany) was advanced along the midline L3-4 or L4-5 intervertebral spaces using a
loss of resistance technique. After negative pressure was detected, a 27-gauge pen-tipped
spinal needle was inserted intrathecally using the needle-through-the-needle technique. After
the free cerebrospinal fluid flow was observed, 1.8 ml 0.5% isobaric bupivacaine (9 mg) and
15 µg fentanyl were administered for 30 seconds. Then, the spinal needle was removed and the
catheter was inserted into the epidural space, and it was advanced 3-5 cm in the space and
controlled with negative pressure, and the catheter was fixed. At the end of the anesthesia
procedure, the patients were placed in the supine position for the operation. The necessary
study drugs were started to be administered to the patients in accordance with the study
group they were assigned to, and infusions were continued throughout the operation.
The level of sensory block was assessed with the pinprick test, and surgery was allowed when
the sensory block reached the upper level of the T12-L1 dermatome. If sensory block did not
occur within the first 20 minutes following the spinal injection, spinal anesthesia was
considered unsuccessful and the patients were excluded from the study. The patients who were
excluded from the study were injected with an additional 5 ml of 2% lidocaine solutions
through the epidural catheter until the sensory block T12-L1 level was achieved, and the
patients were allowed to operate.
If the intrathecal space could not be reached in three unsuccessful attempts, a general
anesthesia protocol was planned and patients requiring general anesthesia were excluded from
the study.
For the measurement of MDA and HO-1 levels, blood samples taken from the patient groups
included in the study were taken for 10-20 minutes for clotting. After the tube was kept in
an upright position, it was centrifuged at +4°C at 4000 rpm for 15 minutes. The serum samples
obtained were aliquoted and placed in a deep freezer at -80˚Ϲ and kept there until the day of
analysis.
Serum malondialdehyde (MDA) and HO-1 levels were measured on the same day in order not to be
affected by the variation between days. Serum MDA and HO-1 levels were determined by ELISA
method, using "Human MDA ELISA Kit" and Human HO-1 ELISA Kit. measured in accordance with the
manufacturer's instructions.
In addition, C-reactive protein (CRP) (mg/dl), calcium (mg/dl), alkaline phosphatase (U/L),
lactate dehydrogenase (U/L), aspartate aminotransferase (U/L), alanine aminotransferase,
which are routinely checked at preoperative, postoperative 2nd and 24th hours. (U/L), glucose
(mg/dl), potassium (nmol/L), iron (ug/dl), total protein (g/dl) and albumin (g/dl) levels in
Beckman Coulter device, ferritin (ng) /ml) Beckman Coulter device, Blood count parameters,
White Blood Cell Count (10^3/mcL), Total Lymphocyte Count (10^3/mcL), Hemoglobin (g/dL) were
studied on Sysmex device.
