跳至主要内容
临床试验/NCT06867302
NCT06867302招募中不适用

Effectiveness of Single Bolus Versus Continuous Infusion of Dexmedetomidine in Mitigating Agitation in Adults Undergoing Nasal Surgery: a Prospective Randomized Trial

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Degree of emergence agitation by Richmond Agitation Sedation Scale (RASS)

研究概览

简要总结

The main objective of study is to compare dexmedetomidine single bolus dose before extubation with continuous infusion as regards their efficacy in mitigating the incidence of emergence agitation in obese adults undergoing nasal surgery.

详细描述

Agitation during emergence from general anesthesia is a potentially serious phenomenon that has not been studied in adults as often as in pediatric population. When agitation, serious self-injury, or violence towards the medical team occur, with the risk of aspiration, bleeding, hypoxia, arrhythmias, or simply pulling the endotracheal tubes, removal of drains or catheters. Moreover, agitated patients are not only at risk of developing complications but also, they are labor intensive as they require more medical attention, rescue drugs, and more attending staff till agitation attack safely subside. Recognized risk factors to develop emergence agitation (EA) in adults include ear, nose, and throat surgery, obesity, sevoflurane anesthesia, endotracheal tube, and history of psychological illness. In adults, adjuvants have been co-administered with general anesthesia in order to negate or reduce the incidence of EA especially in patients with identified risk factors.

dexmedetomidine is a highly selective α2 sympatholytic, has been proposed as an attractive candidate for the prophylaxis of EA. By interacting with α2 receptors in locus coeruleus of the pons, Dex exerts its unique anxiolytic, sedative and sympathetic antagonistic action with no respiratory depression. Moreover, it has pain-modulating effect due to interaction with α2 receptor sites in the dorsal horn and supra-spinal regions.

Nevertheless, there have been conflicting data about Dex optimal dose and time of administration when used as prophylaxis against EA. Indeed, different dosing protocols are associated with over sedation, prolonged extubation time, and delayed post-anaesthesia care unit time.

No premedication. Basic general anesthesia monitoring included electrocardiogram, pulse oximetry, non-invasive arterial pressure, and capnography, were recorded every 5 min. Preoxygenation with 100% oxygen for 5 min was performed before fentanyl 1 μg/kg and propofol 1.5-2 mg/ kg, were administered as induction agents. Intubation with facilitated with atracurium besylate 0.5 mg/ kg. The size of endotracheal tubes was 6.5-7.5 mm, for females and males, respectively. Mechanical ventilation was set on 6 ml/kg tidal volume, and respiratory rate was adjusted to keep end-tidal CO2 between 35 and 40 mmHg, in 50% O2/air. All patients at induction were given dexamethasone 4 mg i.v., ondansetron, 4 mg i.v to prevent post-operative nausea and vomiting, plus Ringers lactate solution 6 mg/ kg drip for basic volume maintenance. Blood loss was compensated for with Ringers lactate, intraoperatively. Maintenance of anesthesia was carried out with Isoflurane, regulated at 2-3%, Titrated incremental doses of atropine 0.5 mg, esmolol 10 mg, and ephedrine 6 mg were given i.v., when HR ≤ 45, HR ≥ 120 and MAP ≤ 60, in the mentioned order. ketorolac 30 mg was given I.M., at the time of nasal packing.

When surgery was finished, gentle suction was attempted, non-depolarizing muscle relaxant reverse with atropine, 0.5 mg and neostigmine 0.02 mg/kg was given. Next, isoflurane was turned off and respiration was then converted back to manual ventilation with 100% oxygen at 7 L/min. The patients were not disturbed, except by continual verbal requests to open their eyes. All other stimuli were prevented. Extubation was done when patients were able to breathe spontaneously and interact with verbal demands. When patients were awake, calm, and sedated, they were transferred to the PACU. Patients were discharged from the PACU when their Aldrete score was ≥ 9.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Apart from the anesthesiologists who performed the blocks, all patients, surgeons, and postoperative nurses remained blinded to randomization throughout the study period.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologist (ASA) Ⅰ or II
  • Adults with body mass index (BMI) < 30 Kg/m
  • Underwent elective nasal surgery.

排除标准

  • Significant comorbidity like hepatic, renal, or cardiac disease
  • Auditory impairment
  • Cognitive dysfunction
  • Substance abuse
  • Allergy to the studied medicines
  • Planned intensive care admission after the surgery.

研究组 & 干预措施

Bolus group

Experimental

single dose 0.5 µg/kg in 15 ml saline over 10 min , started 15 minutes before end of surgery

干预措施: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) (Drug)

Infusion group

Experimental

Infusion of dexmedetomidine at a dose of 0.5 µg/kg/h without loading dose all through intraoperative time

干预措施: Dexmedetomidine Injection [Precedex] (Drug)

结局指标

主要结局

Degree of emergence agitation by Richmond Agitation Sedation Scale (RASS)

时间窗: 5 minutes after operation

RASS is a 10-point scoring system used to assess patient's level of agitation and sedation: 4 levels for agitation, 1 level for normal (alert and calm), and 5 levels of sedation

次要结局

  • Extubation time(3 minutes after removal of endotracheal tube)
  • Intraoperative heart rate(Every 15 minutes along operation)
  • Intraoperative mean arterial blood pressure(Every 15 minutes along operation)
  • Time of first rescue analgesic(5 minutes before first analgesic request)
  • Postanesthesia care unit time(5 minutes after discharge from recovery unit)
  • Incidence of use of midazolam(2 minutes after occurence of emergence agitation)
  • Incidence of bradycardia(2 hours intraoperatively)
  • Incidence of vomiting(24 hours postoperative)
  • Numerical rating score (NRS)(Every 10 min in postanesthesia care unit)
  • Total amount of rescue analgesic(24 hours postoperative)
  • Boezaart Surgical Field Grading Scale(2 hours intraoperatively)
  • Incidence of hypotension(2 hours intraoperatively)
  • Incidence of nausea(24 hours postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasser S Mostafa, MD

Lecturer of Anesthesiology

Fayoum University Hospital

研究点 (1)

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