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NCT Number: NCT06614010

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

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.

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Key information

Conditions

Dexmedetomidine Confusion Delirium Emergence Delirium Fascia Iliaca Block Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Qianfoshan Hospital

Jinan, Shandong, 250000, China

Location status: Recruiting

Location contact

Pengcai Shi, Chief physician

CONTACT

[email protected]

86+13791126828

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of awakening agitation

    Time frame: 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 outcomes

  1. Analgesic effect

    Time frame: 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.

  2. Ramesay score

    Time frame: 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.

  3. Hemodynamic parameters

    Time frame: 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).

  4. Record of laryngeal mask removal time and adverse reactions

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pengcai Shi, Chief physician

CONTACT

[email protected]

13791126828

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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