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

NCT06614010 | Recruiting Phase 1 DMC

• 1 other identifier: LI
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine; Fascia Iliaca Block

Keywords

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

Outcome Measures

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.

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

Secondary Outcomes (4)

• Analgesic effect

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

• Ramesay score

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

• Hemodynamic parameters

  During operation

• Record of laryngeal mask removal time and adverse reactions

  Within 24 hours after surgery

Study Arms (3)

Group S1

EXPERIMENTAL

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: Dexmedetomidine Injection

Group S2

EXPERIMENTAL

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: Ropivacaine and Dexmedetomidine

Group C

ACTIVE COMPARATOR

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.

Drug: Sodium Chloride Injection

Interventions

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.

Group S1

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.

Group S2

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.

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Pengcai Shi, Chief physician

CONTACT

13791126828; shipc1997@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician，Master Tutor

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: February 5, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)