Comparative Dose-Response of Intrathecal Dexmedetomidine for Post-Spinal Shivering

Официальное название

Comparative Efficacy and Dose-Response of Intrathecal Dexmedetomidine in Attenuating Post-Spinal Shivering: Double-Blinded Randomized Controlled Trial

Обзор

Dexmedetomidine, a highly selective α2-adrenergic agonist, when used intrathecally as an adjuvant to local anesthetics, prolongs sensory/motor block and may blunt thermoregulatory shivering mechanisms. Several randomized controlled trials and meta-analyses have demonstrated decreased shivering incidence with intrathecal dexmedetomidine, but reported doses vary (commonly 2.5, 5, and 10 µg, and in some trials up to 15-20 µg), and the balance between efficacy and adverse effects (sedation, bradycardia, and hypotension) is not fully established. Hence, a head-to-head randomized comparison of several low-to-moderate intrathecal doses is warranted. Objective: to compare the safety and efficacy of three intrathecal dexmedetomidine doses (2.5 µg, 5 µg, 10 µg) versus placebo for the prevention of post-spinal shivering.

Вмешательства

• Препарат Group P (Placebo Control Group)
  Patients in this group will receive the standard spinal anesthetic consisting of hyperbaric bupivacaine 0.5% (15 mg) combined with an equivalent volume of normal saline (0.9% NaCl), containing no active dexmedetomidine. The total intrathecal injection volume will be standardized to 3.5 mL across all groups by adjusting the volume of saline added. This group serves as the control to establish the baseline incidence and characteristics of post-spinal shivering and block dynamics without the interv
• Препарат Group D2.5 (Low-Dose Dexmedetomidine Group)
  Patients in this group will receive the standard spinal anesthetic (15 mg hyperbaric bupivacaine 0.5%) supplemented with a low dose of 2.5 µg of dexmedetomidine. Normal saline will be added to achieve the standardized total intrathecal volume of 3.5 mL.
• Препарат Group D5 (Moderate-Dose Dexmedetomidine Group)
  Patients in this group will receive the standard spinal anesthetic combined with a moderate dose of 5 µg of dexmedetomidine. The total volume will be adjusted to 3.5 mL with normal saline.
• Препарат Group D10 (Higher-Dose Dexmedetomidine Group)
  Patients in this group will receive the standard spinal anesthetic supplemented with a higher dose of 10 µg of dexmedetomidine, with normal saline used to standardize the total volume to 3.5 mL.

Первичные конечные точки

• Incidence of clinically significant shivering [Срок оценки: Throughout the intraoperative period until 60 minutes post-spinal.]

Вторичные конечные точки (6)

• Time to first shivering episode [Срок оценки: Intraoperative period, up to 60 minutes post-spinal.]
• Requirement of rescue anti-shivering drug [Срок оценки: Intraoperative period, as needed.]
• Dose of rescue anti-shivering drug [Срок оценки: Intraoperative period, as needed.]
• Sedation level [Срок оценки: Postoperative 24 hour]
• Patient satisfaction [Срок оценки: Postoperatively (e.g., prior to discharge from PACU).]
• Time to first analgesic request [Срок оценки: 24 hours Postoperatively.]

Критерии участия

Критерии включения

• Adult patients (age 18-75 years)
• Scheduled for ureteric stone removal surgery
• ASA(American Society of Anesthesiologists) physical status I, II, or III
• Able to provide informed consent

Критерии исключения

• Known allergy to dexmedetomidine, bupivacaine, or other study medications
• Preexisting bradycardia (heart rate <50 beats per minute)
• Second- or third-degree atrioventricular (AV) block without a pacemaker
• Severe hepatic dysfunction
• Uncontrolled hypotension
• Pregnancy
• Chronic use of α₂-agonists or antagonists (e.g., clonidine, tizanidine)
• Infection at the planned spinal puncture site
• Coagulopathy or bleeding disorder
• Inability to rate or communicate shivering (e.g., language barrier, cognitive impairment)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Al-Azhar University — Cairo

Идентификаторы

NCT: NCT07327879 · RC. 2.12.2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗