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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06614010
Enrollment
207
Registered
2024-09-26
Start date
2023-02-05
Completion date
2025-12-01
Last updated
2024-09-26

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

Conditions

Dexmedetomidine, Fascia Iliaca Block

Keywords

Fascia Iliaca Block, Dexmedetomidine, Emergence Agitation, Ropivacaine, Analgesic Mechanism

Brief summary

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

DRUGDexmedetomidine 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.

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.

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.

Sponsors

Qianfoshan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. age between 18 and 65 years, with no restriction on gender 2. diagnosis of hip joint disease necessitating hip arthroplasty 3. ASA grade I-II 4. no significant cardiopulmonary, hepatic, or renal dysfunction prior to the operation 5. no history of psychiatric disorders or long-term use of sedative medications prior to the operation 6. signing of an informed consent form to voluntarily participate in the study.

Exclusion criteria

1. patients allergic to or with contraindications to ropivacaine or dexmedetomidine 2. patients exhibiting symptoms of agitation or delirium prior to the procedure 3. patients with severe central or peripheral nervous system disorders 4. patients with coagulation disorders or receiving anticoagulant therapy 5. pregnant or breastfeeding women 6. patients who received other medications or treatments prior to the procedure that might affect the study results 7. patients unable to cooperate with the study or intolerant to ultrasound-guided iliofascial block

Design outcomes

Primary

MeasureTime frameDescription
Incidence of awakening agitationpostoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACURiker 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

MeasureTime frameDescription
Analgesic effectpostoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACUThe 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 scorepostoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACUThe 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 parametersDuring operationComparisons 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 reactionsWithin 24 hours after surgeryThe 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.

Countries

China

Contacts

Primary ContactPengcai Shi, Chief physician
shipc1997@163.com13791126828

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026