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Recruiting NCT06614010

Effect of Different Administration Routes of Dexmedetomidine Combined with Ultrasound-Guided Fascia Iliaca Block on Emergence Agitation After Hip Replacement Surgery

Phase I Interventional Dexmedetomidine Fascia Iliaca Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine Injection, Ropivacaine and Dexmedetomidine, Sodium Chloride Injection.
Who it may be relevant to
Registry conditions: Dexmedetomidine, Fascia Iliaca Block. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

To examine the impact of various administration routes of dexmedetomidine in conjunction with ultrasound-guided fascia iliaca block (FIB) on emergence agitation (EA) during the postoperative recovery period after hip replacement surgery.

Interventions

  • Drug Dexmedetomidine Injection
    Before anesthesia induction, an iliac fascia block was administered using 0.375% ropivacaine (30 mL) under ultrasound guidance, followed by conventional anesthesia induction. During the anesthesia maintenance phase, dexmedetomidine was infused intravenously at a rate of 0.5 µg/kg/h.
  • Drug Ropivacaine and Dexmedetomidine
    Before anesthesia induction, an iliac fascia block was administered using a mixture of 0.375% ropivacaine and 1ug/kg dexmedetomidine (30ml) under ultrasound guidance. During the anesthesia maintenance phase, an equivalent volume of 0.9% sodium chloride injection was infused intravenously.
  • Drug Sodium Chloride Injection
    Before anesthesia induction, an iliac fascia block was performed using 0.375% ropivacaine (30 mL) under ultrasound guidance, followed by conventional anesthesia induction. During the anesthesia maintenance phase, an equivalent volume of 0.9% sodium chloride injection was infused intravenously.

Primary outcome measures

  • Incidence of awakening agitation [Time frame: postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU]
Secondary outcome measures (4)
  • Analgesic effect [Time frame: postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU]
  • Ramesay score [Time frame: postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU]
  • Hemodynamic parameters [Time frame: During operation]
  • Record of laryngeal mask removal time and adverse reactions [Time frame: Within 24 hours after surgery]

Eligibility criteria

Inclusion criteria

  • age between 18 and 65 years, with no restriction on gender
  • diagnosis of hip joint disease necessitating hip arthroplasty
  • ASA grade I-II
  • no significant cardiopulmonary, hepatic, or renal dysfunction prior to the operation
  • no history of psychiatric disorders or long-term use of sedative medications prior to the operation
  • signing of an informed consent form to voluntarily participate in the study.

Exclusion criteria

  • patients allergic to or with contraindications to ropivacaine or dexmedetomidine
  • patients exhibiting symptoms of agitation or delirium prior to the procedure
  • patients with severe central or peripheral nervous system disorders
  • patients with coagulation disorders or receiving anticoagulant therapy
  • pregnant or breastfeeding women
  • patients who received other medications or treatments prior to the procedure that might affect the study results
  • patients unable to cooperate with the study or intolerant to ultrasound-guided iliofascial block

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Qianfoshan Hospital — Jinan

Identifiers

NCT: NCT06614010 · LI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗