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临床试验/NCT07843953
NCT07843953尚未招募不适用

Intraoperative Infusion of Dexmedetomidine Versus Lidocaine or Magnesium Sulphate for Enhanced Quality of Recovery After Spine Surgery Fixation

Zagazig University0 个研究点目标入组 117 人开始时间: 2026年9月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
117
主要终点
Quality of Recovery-40 score measured at 24 hours postoperatively

研究概览

简要总结

Thoracolumbar fixation is a major spine surgery; it is performed to stabilize the spine after trauma, deformity or advanced degenerative disease. The primary surgical goals are to restore spinal alignment and achieve solid arthrodesis (fusion). From a surgical view, success is often measured by radiographic outcomes, hardware integrity and fusion rates. As anesthesiologists, we must recognize that technical success does not the same as optimal patient recovery.

This is why the concept of Quality of Recovery (QoR) becomes very important. QoR is a patient-centered outcome that covers more than the absence of surgical complications. It includes rapid return of physical function, pain control, psychological well-being, emotional stability and Patient satisfaction.

Therefore, our focus in the perioperative care shifts the focus from "did the surgery succeed?" to "how we can help the patient to recover physically, mentally, and functionally?" This approach is measured using patient-reported outcomes such as the QoR-15 or QoR-40 questionnaires.

Dexmedetomidine (Precedex) has become one of the most valuable medications in modern anesthesia, especially for surgeries associated with significant pain. As a highly selective α2-adrenergic agonist, dexmedetomidine provides a unique combination of analgesia, anxiolysis, and cooperative sedation without causing respiratory depression; it is helpful during painful procedures such as spine surgery.

When infused intraoperative; Precedex reduces central sensitization and diminishes the stress response to surgical stimuli, resulting in improved intraoperative hemodynamic stability, lower postoperative pain scores, reduced opioid requirements, and a smooth and calm recovery from anesthesia.

Intraoperative intravenous lidocaine infusion has become an important tool for improving postoperative pain control; especially in major surgeries. Although lidocaine is commonly known as a local anesthetic, when given systemically during surgery it works in several meaningful ways: it calms the central nervous system, reduces the body's inflammatory response to tissue trauma, and decreases pain sensitivity that often appears after anesthesia wears off.

Because of these combined effects, patients who receive IV lidocaine typically experience lower postoperative pain scores and need less opioid medications; therefore, avoid many opioid-related side effects such as nausea, sedation and constipation.

Lidocaine infusion not only reduces early postoperative pain but also help for faster recovery, earlier mobilization, and improved overall patient satisfaction.

Magnesium sulfate has become an increasingly valuable tool for anesthesiologists caring for patients undergoing long and painful surgical procedures. During major surgeries, the body's stress response can increase pain and make anesthetic management more challenging.

Magnesium works by blocking NMDA receptors, which are the key player in central sensitization and postoperative hyperalgesia. This means patients wake up with less pain, lower opioid requirements, and often more stable intraoperative vital signs. Many doctors preferred to use magnesium sulphate because it is inexpensive, widely available, and easy to administer as a slow infusion.

详细描述

QoR -40 Questioner:

The QoR-40 contains 40 questions grouped into 5 dimensions:

1. Physical Comfort (12 items)

  1. Able to breathe easily
  2. Have had good sleep
  3. Have felt comfortable
  4. Have had a good appetite
  5. Able to enjoy food
  6. No nausea
  7. No vomiting
  8. Feeling rested
  9. Feeling warm and comfortable
  10. No shivering
  11. No sweating
  12. Have had good general comfort

2. Emotional State (9 items) 13. Been able to feel relaxed 14. Been in control 15. Been able to enjoy company of others. 16. Felt anxious 17. Felt angry or irritable 18. Felt depressed 19. Felt lonely 20. Felt confused 21. Felt frightened 3. Physical Independence (5 items) 22. Able to look after personal toilet and hygiene unaided 23. Able to write (or use your phone) 24. Able to speak normally 25. Able to wash yourself 26. Able to dress yourself 4. Psychological Support (7 items) 27. Able to communicate with family or friends 28. Able to communicate with hospital staff 29. Feeling supported by hospital staff 30. Feeling understood by others 31. Feeling supported by family or friends 32. Feeling able to share worries or concerns 33. Feeling encouraged by others 5. Pain (7 items) 34. Moderate pain 35. Severe pain 36. Headache 37. Muscle pains 38. Back pain 39. Sore throat 40. Pain affecting sleep

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
预防
盲法
双盲 (受试者、医护人员)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • Patient acceptance.
  • Patients age between 18-60 years old.
  • 2- Both sexes. 3- Physical status from ASA I to III. 4- BMI ≥ 18 kg/m2 & ≤ 35 kg/m2. 5- Patient acceptance with written consent. 6- Elective lumbar fixation double level surgery

排除标准

  • Uncooperative patient.
  • Allergy to study drugs.
  • Patients on chronic alcohol, opioid, tranquilizer or sedative use.
  • Pregnancy.
  • Emergency surgery

研究组 & 干预措施

Group (L) LIDOCAINE

Active Comparator

the patient will receive lidocaine IV infusion, loading dose (1.5 mg) diluted in 10 cm 0.9% saline given bolus then (1.5-2 mg/kg/h) will start after induction of anesthesia until the end of surgery.

干预措施: Group ( L): LICOCAINE (Drug)

Group (M)

Active Comparator

the patient will receive Magnesium sulphate IV infusion, loading dose (30 mg/kg diluted in 10 cm 0.9% saline over 10-30 min than 6-20 mg/kg/h) will start after induction of anesthesia until the end of surgery.

干预措施: Group M: Magnesium sulphate (Drug)

Group (D)

Active Comparator

the patient will receive Dexmedetomidine IV infusion, loading dose (0.5 -1 mcg/kg) diluted in 10 cm 0.9% saline given bolus then (0.2-0.7mcg/kg/h) will start after induction of anesthesia until the end of surgery.

干预措施: GROUP Dexmedetomidine (Drug)

结局指标

主要结局

Quality of Recovery-40 score measured at 24 hours postoperatively

时间窗: 24 hours postoperatively

Quality of Recovery-40 contains 40 questions grouped into 5 dimensions: 1. Physical Comfort (12 items) 2. Emotional State (9 items) 3. Physical Independence (5 items) 4. Psychological Support (7 items) Scoring Each item is scored on a 5-point Likert scale: 1. = None of the time 2. = Some of the time 3. = Usually 4. = Most of the time 5. = All of the time Total score range: 40-200 * 150-200 --- excellent recovery * 140-159 --- good recovery * Less than 140 --- moderate recovery

次要结局

  • visual analogue scale(at 2,4,6,8,12,24,48 hours after surgery)

研究者

申办方类型
其他政府机构
责任方
主要研究者
主要研究者

Asmaa Mohammed Galal El-Deen

Associative professor

Zagazig University

标识符

NCT 编号
NCT07843953
其他研究编号
Zagazig M

日期

首次提交
(上个月)
首次发布
(前天)
主要完成日期
(2个月后)
研究完成日期
(3个月后)
最近核实
(29天前)
最近更新
(前天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
是

planned after the completion of the study publication

是否有结果
否

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