A Phase 4 interventional study of Dexmedetomidine & Bupivacaine. and Bupivacaine Only. in Anesthesia, Spinal, sponsored by Cairo University. Completed. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-02.
Sponsored by Cairo University · Phase 4, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Dexmedetomidine \& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 5 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.
Drug: Dexmedetomidine & Bupivacaine.
Dexmedetomidine \& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 10 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.
Drug: Dexmedetomidine & Bupivacaine.
Dexmedetomidine \& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 15 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.
Drug: Dexmedetomidine & Bupivacaine.
Bupivacaine Only. Patients will receive intrathecal 12.5 mg isobaric bupivacaine only using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.
Drug: Bupivacaine Only.
Intrathecal injection of Dexmedetomidine \& Bupivacaine.
Intrathecal injection of Bupivacaine only.
The time to two sensory block segment regression.
Define the start of regression of the level of sensory block
Time frame: 70 min
The peak sensory level of the block.
By Pin Prick testing.
Time frame: 10 min
Time from intrathecal injection to peak sensory block level.
Define the speed of onset of the block.
Time frame: 10 min
Time to S1 level sensory regression.
Define duration of the block.
Time frame: 70 min
Degree of motor block.
By Modified Bromage Score.
Time frame: 24 h
Intraoperative hemodynamic variables.
Detect frequency of side effects
Time frame: 24 h
The total dose of ephedrine/atropine required to maintain hemodynamic stability.
Detect frequency of side effects
Time frame: 24 h
The amount of lactated Ringer's solution required intraoperatively to maintain normal Blood pressure range
Detect frequency of side effects
Time frame: 24 h
Oxygen saturation (the need for O2 supplementation)
Detect frequency of side effects
Time frame: 24 h
Intraoperative analgesic supplementation
Define quality of the block
Time frame: 70 min
Time to first postoperative rescue analgesic request
Define duration of analgesia by the block
Time frame: 24 h
Postoperative pain scores for 24 hours
Define duration of analgesia by the block
Time frame: 24 h
Frequency of administration of postoperative analgesics
Define duration of analgesia by the block
Time frame: 24 h
Intraoperative sedation scores
Detect frequency of side effects
Time frame: 24 h
Incidence of side effects (nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation)
Detect frequency of side effects
Time frame: 24 h
New born Apgar Score
Detect any effects on the new born at different dose levels
Time frame: 5 min
Duration of motor block.
By Modified Bromage Score.
Time frame: 24 h
Early postoperative hemodynamic variables.
Detect frequency of side effects
Time frame: 24 h
Total dose of postoperative analgesics
Define duration of analgesia by the block
Time frame: 24 h
Postoperative sedation scores
Detect frequency of side effects
Time frame: 24 h
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Cairo University