Skip to main content
OpenTrials
Completed

NCT Number: NCT06785285

Comparative Study of Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine in Cesarean Section

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University Hospital

Sohag, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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 names: fentanyl 25 ug

Primary outcomes

  1. Pain Relief

    Time frame: from 0 hours to 6 hours after the procedure

    Patient's pain score will be assessed using visual analogue scale (VAS); scored from 0-10 (where 0=no pain and 10=the worst pain imaginable) during the recovery room (T0) and at one, three, and six hours (T1, T3, and T6) in the postoperative period.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 21, 2025
Registry last updated
Jan 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.