Not Yet RecruitingPhase 2Phase 3ACTRN12623000153617

Dexmedetomidine as an adjuvant to levobupivacaine for spinal anaesthesia in elderly patients undergoing hip replacement surgery: Prospective, randomised, double-blinded study.

Efficacy of dexmedetomidine as an adjuvant to levobupivacaine for spinal anaesthesia in elderly patients undergoing hip replacement surgery: Prospective, randomised, double-blinded study.


Sponsor

University Hospital Centre Sestre Milosrdnice

Enrollment

60 participants

Start Date

Mar 1, 2023

Study Type

Interventional

Conditions

Summary

Spinal anesthesia is a preferred method of anesthesia for lower limb surgery. Antinociceptive synergism between local anesthetics and opioids is well studied. Together they provide superior and effective anesthesia, prolong the duration and effectiveness of postoperative analgesia without prolonging motoric block but with possible side effects (hemodynamic instability, respiratory depression). Dexmedetomidine, selective alpha2-agonist, is well examined as an adjuvant to peripheral nerve blocks, but relatively new as a intrathecal agent. The main goal of this study is to compare opioids with dexmedetomidine as adjuvant to spinal anesthesia, especially their effect on hemodynamic stability in elderly patients. Hypothesis of this study is that dexmedetomidine offers equal quality of spinal anesthesia with lower incidence of side effects.


Eligibility

Sex: Both males and femalesMin Age: 70 Yearss

Inclusion Criteria3

  • Patients undergoing hip replacement surgery.
  • Patients 70 years old or older
  • ASA II, III

Exclusion Criteria7

  • Patients height less than 150 cm.
  • Aortic valve stenosis gr 3+
  • Allergies
  • Coagulopathy
  • Patient refusal
  • Elevated ICP
  • Puncture point infection

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Interventions

Spinal anesthesia will be performed on thirty ASA Grade II and III geriatric patients undergoing hip surgery. Before the procedure all patients will receive 500mL of intravenous saline. Noninvasive b

Spinal anesthesia will be performed on thirty ASA Grade II and III geriatric patients undergoing hip surgery. Before the procedure all patients will receive 500mL of intravenous saline. Noninvasive blood pressure, heart rate and SpO2 were noted every 5 minutes. Patients will be randomly assigned into two groups. Subject group(n=30) will receive once only spinal anesthesia with levobupivacaine by body height nomogram and 5 mcg of dexmedetomidine intrathecally(Doses and effects of levobupivacaine and bupivacaine for spinal anaesthesia M. del-Rio-Vellosillo, J.J. Garcia-Medina, M.D. Pinazo-Duran, A. Abengochea-Cotaina; British Journal of Anaesthesia Volume 113, Issue 3, September 2014, Pages 521-522). Administration will occur 30 minutes prior to the first incision. Dexmedetomidine will be administered intrathecally concurrently with levobupivacaine. Groups will be compared by hemodynamic parameters, use of vasopressors, duration of motoric and sensoric block, duration and quality of postoperative analgesia and side effects: bradycardia, hypotension, respiratory depression.


Locations(1)

City of Zagreb, Croatia

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ACTRN12623000153617