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

Phase 1

Recruiting

• Conditions: Dexmedetomidine; Fascia Iliaca Block
• Interventions: Drug: Dexmedetomidine Injection; Drug: Ropivacaine and Dexmedetomidine; Drug: Sodium Chloride Injection

• Registration Number: NCT06614010
• Lead Sponsor: Qianfoshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-05
• Status Verified: 2024-09
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-26
• Last Update Posted: 2024-09-26
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group S1	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.
Group S2	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.
Group C	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

Name	Time	Method
Incidence of awakening agitation	postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU	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 Outcome Measures

Name	Time	Method
Analgesic effect	postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU	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	postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU	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	During operation	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	Within 24 hours after surgery	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.

Trial Locations

Locations (1)

Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China