Intrathecal Dexmedetomidine With Bupivacaine for Spinal Anesthesia in Cesarean Section
Information source: Cairo University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia, Spinal
Intervention: Dexmedetomidine & Bupivacaine. (Drug); Bupivacaine Only. (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Cairo University
Summary
A Randomized, Controlled, Double blind study aiming to evaluate the analgesic potentials and
side effect profile of different dose levels of Dexmedetomidine added to subarachnoid
bupivacaine in full-term pregnant women undergoing elective cesarean section using spinal
anesthesia. The investigators ultimate goal is to find out the least effective dose which
will be associated with minimal or no side effects. The primary outcome will be the time to
two sensory block segment regression.
Clinical Details
Official title: Effects of Intrathecal Dexmedetomidine on the Perioperative Clinical Profile of Bupivacaine-induced Spinal Anesthesia for Cesarean Section
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The time to two sensory block segment regression.
Secondary outcome: The peak sensory level of the block.Time from intrathecal injection to peak sensory block level. Time to S1 level sensory regression. Degree of motor block. Intraoperative hemodynamic variables. The total dose of ephedrine/atropine required to maintain hemodynamic stability. The amount of lactated Ringer's solution required intraoperatively to maintain normal Blood pressure range Oxygen saturation (the need for O2 supplementation) Intraoperative analgesic supplementation Time to first postoperative rescue analgesic request Postoperative pain scores for 24 hours Frequency of administration of postoperative analgesics Intraoperative sedation scores Incidence of side effects (nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation) New born Apgar Score Duration of motor block. Early postoperative hemodynamic variables. Total dose of postoperative analgesics Postoperative sedation scores
Detailed description:
Alpha 2-agonists are non-opioid adjuvants with a significant role in extending the analgesic
duration of subarachnoid block. When clonidine or Dexmedetomidine was added to intrathecal
local anesthetics, the regression of sensory and motor blocks increased dose-dependently.
Further, a recent meta-analysis including seven randomized controlled studies reported an
increase in the duration of analgesia and reduced morphine requirement after the concomitant
subarachnoid administration of clonidine.
Animal studies demonstrated that Dexmedetomidine added to bupivacaine significantly enhanced
the duration of sensory and motor blockade of sciatic nerve block. Histo-pathological
examination proved that all of the nerves analyzed had normal axons and myelin at 24 h and
14 days after the peri-neural administration of Dexmedetomidine. Several clinical studies
confirmed the analgesic potentials and safe neurological outcome of neuraxially administered
Dexmedetomidine in the non-obstetric settings while intrathecal clonidine proved to be a
useful analgesic adjunct for spinal anesthesia in patients undergoing cesarean section. But
to the best of the investigator knowledge the effects of intrathecal Dexmedetomidine on the
perioperative clinical profile of bupivacaine-induced spinal anesthesia were not studied
before in the obstetric patient population.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Full-term pregnant women.
- Elective cesarean section using spinal anesthesia.
- Singleton gestation.
- American Society of Anesthesiologists (ASA) physical status classes I and II.
Exclusion Criteria:
- Preterm pregnancy (<37 wks gestation).
- Multiple gestation.
- Cardiovascular disease (e. g., preeclampsia, hypertension) and the use of
antihypertensive medication.
- Conditions that preclude spinal anesthesia.
- Failed spinal block and conversion to general anesthesia.
- A history of established chronic pain.
- Drug addiction.
- A psychiatric disorder.
- Inability to communicate effectively.
- Asthma and allergy to non-steroidal anti-inflammatory drugs.
Locations and Contacts
Additional Information
Starting date: December 2014
Last updated: February 11, 2015
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