A Randomized Clinical Study to Compare Different Doses of Clonidine to Fentanyl as an Adjuvant to Hyperbaric Bupivacaine 0.5% for Spinal Anesthesia in Patients Undergoing LSCS
Description:
All the patients selected for study will have a detailed general examination including airway
assessment, spine, and systemic examination .Patient will be kept nil-by-mouth for 6 to 8
hours. Sedatives and hypnotics will be avoided in premedication as well as
intraoperatively.All patients will be premedicated with antiemetic agent – Inj ondansetron(4
mg). In O.T. patient will be preloaded with R.L. 10-15 mL/kg.Pre-operative parameters like
pulse rate, respiratory rate, oxygen saturation and blood pressure will be noted.
Procedure
Spinal anaesthesia will be given with 25G Quinke’s needle in sitting position. Under all
aseptic precautions and depending upon the groups, respective agents will be injected
intrathecally.That is Group BC15 will be given 2ml of hyperbaric bupivacaine 0.5%with 15 mcg
clonidine intrathecally; Group BC30 will be given 2ml of hyperbaric bupivacaine 0.5% with 30
mcg clonidine intrathecally;Group BC60 will be given 2ml of hyperbaric bupivacaine 0.5% with
60 mcg clonidine intrathecally Group BF25 will be given 2ml of hyperbaric bupivacaine 0.5%
with 25mcg of fentanyl intrathecally.Each group will have a total volume of 2.5 ml made by
addition of Normal saline Both the patient and anesthesiologist will be blinded to the study
solutions. Syringes will be prepared immediately before the spinal injection ensuring the
volumes at 2.5ml by third person knowing the code to blind the Anaesthesiologist
administering the drug and later on making the observations. Pulse and blood pressure will be
measured every 5 minutes for first 30minutes and thereafter every 10 minutes.Sensory block
will be tested by pinprick method. Degree of motor blockade will be assessed by modified
Bromage scale. In the intraoperative period, patient will be closely monitored for pulse
rate, respiratory rate, SpO2, blood pressure and blood loss.
– Any side effects such as nausea, vomiting, pain, shivering, pruritis, sedation
hypotension, bradycardia,urinary retention and respiratory discomfort will be noted and
treated with appropriate drugs. Inj oxytocin 10U will be added to R.L. after delivery of
anterior shoulder. Residual sensory blockade will be monitored and its wearing off time
will be noted(when sensation to pin-prick regresses by 2 dermatomal segments).
– Residual motor blockade will be monitored and its wearing off time will be noted(when
patient starts to lift legs against gravity) Post operative analgesic drugs will be
given when patient’s VAS score reaches > 7. (this will be taken as the time of wearing
off analgesia) and the time of injection of first analgesic drug.(Inj Voveran 75mg
i.m.)will be noted.VAS involves us of a 10cm line on a piece of white paper and it
represents patients opinion of degree of pain.It will be explained to all patients
preoperatively that one end of the line i.e ‘0’ marks "no pain" at all, while other end
i.e ’10’ represents "worst pain" she ever felt. Patient will rate the degree of pain by
making a mark on the scale. Thus the pain score will be obtained by measuring the
distance from the ‘0’ end to the indicated mark.
Pain score 0-3 mild 3-7 moderate >7 severe The various data obtained, including different
parameters measured at different time intervals, will be calculated and compared with
baseline values within each group as well as with corresponding times among the groups, using
appropriate test of significance. p value less than 0.05 will be taken as significant. The
data will be presented by constructing various tables and graphs.
Condition:
Full Term Pregnant Patients
Treatment:
Fentanyl
Start Date:
August 2010
Sponsor:
Pravara Institute of Medical Sciences University
For More Information:
https://clinicaltrials.gov/show/NCT01205204