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

NCT ID: NCT06614010

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-05

Study Completion Date

2025-12-01

Brief Summary

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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

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Conditions

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Dexmedetomidine Fascia Iliaca Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group S1

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 Type EXPERIMENTAL

Dexmedetomidine Injection

Intervention Type 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 S2

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 Type EXPERIMENTAL

Ropivacaine and Dexmedetomidine

Intervention Type 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 C

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 Type ACTIVE_COMPARATOR

Sodium Chloride Injection

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pengcai Shi

Chief physician,Master Tutor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qianfoshan Hospital

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Pengcai Shi, Chief physician

Role: CONTACT

13791126828

Facility Contacts

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Pengcai Shi, Chief physician

Role: primary

86+13791126828

Other Identifiers

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LI

Identifier Type: -

Identifier Source: org_study_id

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