Clinical trial NCT06785285: Comparative Study of Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine in Cesarean Section
Official title: Comparative Study of Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The quality of the spinal anesthesia has beenreported to be improved by the addition of opioids (such as morphine, fentanyl and sufentanil) and other drugs (such as dexmedetomidine, clonidine, magnesium sulfate (Mg), neostigmine, ketamine, and midazolam).

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

Detailed description: Spinal anesthesia is still the first choice for cesarean section due to its deep sensoryblock as well as fewer side effects on mother and fetus. Despite many benefits ofthismethod, it has a short duration and cannot provide sufficient postoperativeanalgesia.Adequate postoperative analgesia plays a crucial role in cesarean delivery because itallows better breastfeeding and caring for newborns.

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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women in the childbearing period
* 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:

* The patients with emergency conditions,
* 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

Primary outcomes:
measure: Pain Relief
timeFrame: from 0 hours to 6 hours after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
affiliation: Sohag University, Faculty of medicine
name: Nehal samir esmail, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: