An interventional study of Dexmedetomidine 0.5 mcg and Dexmedetomidine 1 mcg in Analgesia, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to female participants aged 19 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-06-23.
Sponsored by Mansoura University · Not applicable, Interventional, and Prevention
Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.
Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) Dexmedetomidine is a potent and highly selective α2 adrenergic receptor agonist, exerts its sympatholytic effect by inhibiting the release of noradrenaline from central and peripheral sympathetic nerve endings. It is considered to be a useful agent with a wide safety margin, excellent sedative capacity and moderate analgesic properties
This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of two different doses (0.5 mcg/kg and 1mcg/kg) of dexmedetomidine as an adjuvant to isobaric bupivacaine in TAPB compared to a control group on the postoperative analgesia in cesarean section under spinal anaesthesia
Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline 0.9% for each side
After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline containing 0.5 mcg/kg dexmedetomidine for each side
Drug: Dexmedetomidine 0.5 mcg
After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0. 5% plus 10 mL normal saline containing 1 mcg/kg dexmedetomidine for each side
Drug: Dexmedetomidine 1 mcg
0.5 mcg/kg
1 mcg/kg
The time of the first postoperative analgesic requirement
Time frame: during the first 24 postoperative hours
Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the
mg
Time frame: during the first 24 postoperative hours
The visual analog scale (VAS) scores during rest
11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively
Time frame: during the first 24 postoperative hours
The visual analog scale (VAS) scores during movement
11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively
Time frame: during the first 24 postoperative hours
Mean arterial blood pressure (MBP)
mmHg
Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
heart rate (HR)
beat per minute
Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Patient satisfaction about the quality of postoperative analgesia
poor = 1, fair = 2, good = 3, excellent = 4
Time frame: during the first 24 postoperative hours
The side effects (nausea, vomiting, abdominal colic and lower limb weakness)
incidence
Time frame: during the first 24 postoperative hours
the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome
Time frame: during the first 24 postoperative hours
The level of sedation
using a 4-point scale (0 = awake and alert, 1 = minimally sedated, responds to speech, 2 = moderately sedated, arousable by tactile stimulation, and 3 = deeply sedated, arousable only by painful stimulation)
Time frame: during the first 24 postoperative hours
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Mansoura University