drugset / Trial / NCT07035223

Clinical Comparative Study Aiming to Evaluate Postoperative Effect of Using Intrathecal Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Lower Limb Vascular Surgeries on Pain Intensity, Analgesic Requirement and Shivering. Patients and Methods After Approval of Medical Institution

NCT07035223 ↗

Phase 4 Completed 40 enrolled Nashwa Ahmed
RandomizedParallel-groupQuadruple-blindOther

Summary

Spinal anaesthesia is an excellent choice of numerous operating procedures. This is due to its effectiveness, rapid onset of action, easy to implement, patient stayed awake, and minimal drug cost.(1) It is also beneficial for patients with chronic airway disorders, reducing the risk of pulmonary aspiration and vomiting in patients with full stomach, as well as its fewer adverse effects, and speedy patient turnover. (2,1) In lower abdominal and lower limb surgeries, spinal anaesthesia is still the primary option. (3) The resultant nerve block is sufficient for patient welfare, while motor block eases the surgeon's work. Moreover, it grants efficient pain relief in the early post-operative period. (2) Yet, postoperative analgesia is a most important dilemma. (4) Thus, additional pain control is essential after spinal anaesthesia effect fades. Consequently, effective analgesia is crucial to accelerate rehabilitation and return to proper functional ability. Post-operative analgesia can be accomplished by numerous approaches specifically systemic opioid and non-opioid, local wound infiltration and peripheral nerve blocks, each approach have its own advantages and drawbacks.

Timeline

Start
2025-04-08
Primary completion
2025-05-08
Completion
2025-05-30

Publications

  • Results Bhure A, Jagtap N. A comparison of intrathecal dexmedetomidine and fentanyl as an adjuvant to isobaric levobupivacaine for lower limb orthopaedic surgery. Indian Journal of Clinical Anaesthesia 2019;6(1):89-96.
  • Results Chandra GP, Krishna SS, Singh P. Comparison of effect of intrathecal dexmedetomidine and clonidine as an adjuvant to hyperbaric bupivacaine in patients undergoing surgery for fracture femur and tibia. Int Surg J. 2017 Dec;4(12):3833-3838.
  • Results Reddy NG, Sekar RG, Ahmed CJ, Himabindu M, Mallika CH, Tejaswini PK. Intrathecal nalbuphine versus dexmedetomidine as an adjuvant in spinal anaesthesia for lower limb and lower abdominal surgeries. Journal of Cardiovascular Disease Research 2023;14(2): 825-830.
  • Results Ahmed SA, Lotfy HA, Mostafa TAH. The effect of adding dexmedetomidine or dexamethasone to bupivacaine-fentanyl mixture in spinal anesthesia for cesarean section. J Anaesthesiol Clin Pharmacol. 2024 Jan-Mar;40(1):82-89. doi: 10.4103/joacp.joacp_396_22. Epub 2024 Mar 14.
  • Results Zhang Y, Shan Z, Kuang L, Xu Y, Xiu H, Wen J, Xu K. The effect of different doses of intrathecal dexmedetomidine on spinal anesthesia: a meta-analysis. Int J Clin Exp Med 2016;9(10):18860-18867.
  • Results Khare A, Chohala M, Thada B , Mathur V, Garg D , Tanwar N. A study to compare the efficacy of intrathecal dexmedetomidine versus nalbuphine as an adjuvant to 0.5% hyperbaric bupivacaine for postoperative analgesia in lower abdominal surgeries. Ain-Shams Journal of Anesthesiology 2022;14(1):31.

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 4 ug Intrathecal
Comparator Fentanyl Other / unclassified 25 ug Intrathecal
Comparator Bupivacaine Other / unclassified 0.5 % Intrathecal
Comparator Bupivacaine Other / unclassified 3 ml Intrathecal

Indications

No indication recorded.