Comparison of Different Doses of Clonidine to Fentanyl as an Adjuvant to Bupivacaine 0.5% for Spinal Anesthesia
Information source: Pravara Institute of Medical Sciences University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Full Term Pregnant Patients; Undergoing Lower Segment Caesarian Section
Intervention: Fentanyl (Drug); Clonidine (Drug); Clonidine (Drug); clonidine (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: Pravara Institute of Medical Sciences University Official(s) and/or principal investigator(s): Dr.Mrs. Bhavini B Shah, MBBS DA, Principal Investigator, Affiliation: Pravara Institute of Medical Sciences Dr.Mrs.Smita S Joshi, MD DA, Principal Investigator, Affiliation: Pravara Institute of Medical Sciences
Summary
The purpose of this study is to evaluate the safety, quality and duration of block with the
addition of Clonidine in different doses to 0. 5% heavy bupivacaine, and to compare it with
addition of Fentanyl to 0. 5% heavy bupivacaine in sub- arachnoid block.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Duration of block
Secondary outcome: Demographic characteristicsMaternal safety Maternal side effects Foetal safety Quality of block Duration of postoperative analgesia
Detailed 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.
Eligibility
Minimum age: 20 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Undergoing Lower Segment Caesarian Section
- ASA grade I or II
- Not having any complicated pregnancy
- Not having any systemic disorders.
- Age group 20 - 35 years
Exclusion Criteria:
- Not willing for spinal anaesthesia
- Unwilling to get enrolled in this study.
- Complicated pregnancy like pregnancy induced hypertension, placenta previa, abruptio
placenta.
- Systemic disorders like diabetes, heart disease, chronic hypertension, pulmonary
disease
- With acute fetal distress.
- With bleeding or coagulation disorders.
- Maternal haemorrhage leading to hypovolemia.
- Height less than 145 cms
Locations and Contacts
Additional Information
Starting date: August 2010
Last updated: September 23, 2010
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