About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Dexmedetomidine Injection
DrugBefore 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.
Ropivacaine and Dexmedetomidine
DrugBefore 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.
Sodium Chloride Injection
DrugBefore 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.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of awakening agitation
Riker sedation-agitation scale (SAS) scores were recorded at various time points during the postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU for each group. These scores were used to evaluate the sedation and agitation status of the patients.
Secondary outcomes
Analgesic effect
The analgesic effect was recorded at various time points during the postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU for each group. Analgesia was assessed using the Numerical Rating Scale (NRS), which ranges from 0 to 10, with higher scores indicating more severe pain.
Ramesay score
The sedation effect of patients in each group was recorded at various time points during the postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU. Sedation was assessed using the Ramsay scale, which consists of 6 grades, with higher scores indicating deeper levels of sedation.
Hemodynamic parameters
Comparisons of hemodynamic parameters among the three groups were made at several time points: after admission (T0), upon completion of anesthesia induction (T1), at the start of surgery (T2), one hour into the surgery (T3), at the end of surgery (T4), and at the removal of the laryngeal mask (T5). The parameters assessed included changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and oxygen saturation (SpO2).
Record of laryngeal mask removal time and adverse reactions
The time of laryngeal mask removal was documented in detail for all three patient groups. Additionally, attention was given to monitoring and recording any adverse reactions occurring during the perioperative period.
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