Comparative Study of Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine in Cesarean Section
NCT ID: NCT06785285
Last Updated: 2025-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2024-03-01
2024-10-10
Brief Summary
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Opioids such as fentanyl in combination with bupivacaine improvesthe quality of intraoperative and early postoperative subarachnoid block. Although, fentanylensures superior quality of analgesia, it is associated with many side effects. This has directed theresearch toward the use of newer and betteradjuvants for spinal anesthesia such as clonidineand dexmedetomidine
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Detailed Description
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Dexmedetomidine is a relatively newer highly selectivealpha-2 adrenoceptor agonist agent that producesanalgesic and sedative effects. It has also been used asan adjuvant in Spinal anesthesia resulting in prolonged duration ofblock and improved postoperative analgesia without anyassociated hypotension or other adverse events
Fentanyl is a synthetic opioid with central action,which is used widely for pain control. Intrathecal fentanyl is usually added to other local anesthetics to increase anesthesia and analgesia. It has improved spinal anesthesia and reduced the anesthetic drug-related side effects including pruritus,nausea, and vomiting.
Adjuvant drugs added to the intrathecal bupivacaine can decrease the dose of local anesthetics and guarantee sensory and motor block. Intrathecal adjuvants include fentanyl and dexmedetomidine as receptor agonists, which have sedative, analgesic, perioperative sympatholytic, anesthetic-sparing, and hemodynamic-stabilizing properties.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group A
About 30 patients received Dexmeditomidine 5 ug and added to it 10 mg hyperbaric bupivicaine 0.5 % .
Dexmedetomidine
To compare the effects of fentanyl and dexmedetomidine when used as adjuvants to intrathecal bupivacaine in elective cesarean section, assessing their impact on the onset and duration of spinal anesthesia, quality of analgesia, hemodynamic stability, incidence of side effects, and neonatal outcomes
Group B
About 30 patients received fentanyl 25 ug and added to it 10 mg hyperbaric bupivicaine 0.5 % .
Dexmedetomidine
To compare the effects of fentanyl and dexmedetomidine when used as adjuvants to intrathecal bupivacaine in elective cesarean section, assessing their impact on the onset and duration of spinal anesthesia, quality of analgesia, hemodynamic stability, incidence of side effects, and neonatal outcomes
Interventions
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Dexmedetomidine
To compare the effects of fentanyl and dexmedetomidine when used as adjuvants to intrathecal bupivacaine in elective cesarean section, assessing their impact on the onset and duration of spinal anesthesia, quality of analgesia, hemodynamic stability, incidence of side effects, and neonatal outcomes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged 18 to 40 years
* Gestational age ≥37 weeks of pregnancy
* ASA I and II candidates for elective cesarean section under spinal anesthesia.
Exclusion Criteria
* Contraindication of spinal anesthesia,
* History of valvular heart disease,
* History of allergy or sensitivity to applied drugs and
* Patients with placenta previa
* Failed blockade or need for induction of general anesthesia
18 Years
40 Years
FEMALE
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Nehal Samir Esmail
Lecturer of Anesthesia, intensive care and pain management Faculty of Medicine
Principal Investigators
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Nehal samir esmail, Lecturer
Role: PRINCIPAL_INVESTIGATOR
Sohag University, Faculty of medicine
Locations
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Sohag University Hospital
Sohag, , Egypt
Countries
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Other Identifiers
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Nehal Samir
Identifier Type: -
Identifier Source: org_study_id
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