Health Care Clinical Trial
Official title:
The Comparison of Hyperbaric Bupivacaine Plus Fentanyl and Hyperbaric Levobupivacaine Plus Fentanyl Administered Intrathecally in Patients Undergoing Elective Cesarean Section
Aim of the Study To compare the effects of hyperbaric bupivacaine plus fentanyl with hyperbaric levobupivacaine plus fentanyl on spinal block quality, haemodynamics and need for analgesics in patients undergoing elective cesarean section. Our hypothesis is that hyperbaric levobupivacaine will provide equal block quality, but better haemodynamic conditions compared to hyperbaric bupivacaine.
Material - Method 60 patients, American Society of Anesthesiology (ASA) group I-II, between
the ages of 18-45 who were scheduled for elective cesarian section under regional anesthesia
are going to be included. Patients with contraindications to regional anesthesia, known
allergy, suffering from pregnancy induced hypertension or placenta previa will be excluded
from the study.
Patients will not be premedicated. After routine monitorization , IV access and fluid
replacement patients will be separated to two groups on a randomised manner. Under sterile
conditions spinal anesthesia will be performed in the sitting position at the level L3-4 or L
4-5 via epidural-spinal combined including a 27 G spinal needle.
Group 1 will receive 8 mg hyperbaric bupivacaine plus 20 mcg fentanyl /2ml intrathecally.
Group 2 will receive 8 mg hyperbaric levobupivacaine plus 20 mcg fentanyl/2ml intrathecally.
The Hyperbaric form of Levobupivacaine is not available on market , so it will be prepared
with the addition of % 30 dextrose by another anesthesiologist who will be blinded to the
patients.
Preparation: 2 ml of %0,75 levobupivacaine + 0,8 mL %30 dextrose + 0,2 mL of saline will be
mixed. So it will contain 5 mg levobupivacaine and %8 dextrose per ml.
Hypotension will be defined as a decrease in blood pressure more than % 30 percent of the
basal measured systolic arterial pressure. Hypotension will be treated with 250 ml fast
saline infusion and if no response with 5 mg of ephedrine IV. A heart rate under 50 beats/min
will be defined as bradycardia and will be treated with 0.5 mg atropine i.v.. If the
anesthesia is not sufficient 10 ml of % 0.25 levobupivacaine wil be administered through the
epidural catheter. The level of sensory and motor block will be evaluated and recorded every
3 minutes at the beginning and after 15 minutes it will be checked every 5 minutes until the
end of surgery. Maximum level of sensory block, time to reach T4 dermatome and time to
regression of 2 segments will be recorded. Nausea-vomiting, pruritus and shivering will also
be recorded. Baby delivery time, which will be defined as the time from spinal medication to
clamping of the umbilical cord will also be recorded. Total time of surgery will also be
recorded. The time for the first analgesic requirement will be noticed as well. Patient and
surgeon satisfaction will also be evaluated.
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