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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorQianfoshan Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine Injection

    Drug

    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.

  • Ropivacaine and Dexmedetomidine

    Drug

    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.

  • Sodium Chloride Injection

    Drug

    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.

Treatment groups

207 Participants
are divided into 3 treatment groups
Group A: Group S1Experimental treatment 1 intervention
Group B: Group S2Experimental treatment 1 intervention
Group C: Group CActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU

Secondary outcomes

1

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.

Time frame
postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU
2

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.

Time frame
postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU
3

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).

Time frame
During operation
4

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.

Time frame
Within 24 hours after surgery

Other outcomes

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