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.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623000153617

Enrollment

Registered

2023-02-16

Start date

2023-03-01

Completion date

2023-05-31

Last updated

2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

70 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients undergoing hip replacement surgery. 2. Patients 70 years old or older 3. ASA II, III

Exclusion criteria

1. Patients height less than 150 cm. 2. Aortic valve stenosis gr 3+ 3. Allergies 4. Coagulopathy 5. Patient refusal 6. Elevated ICP 7. Puncture point infection

Outcome results