Comparative Dose-Response of Intrathecal Dexmedetomidine for Post-Spinal Shivering
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group P (Placebo Control Group), Group D2.5 (Low-Dose Dexmedetomidine Group), Group D5 (Moderate-Dose Dexmedetomidine Group), Group D10 (Higher-Dose Dexmedetomidine Group).
- Who it may be relevant to
- Registry conditions: Post-Spinal Shivering. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Efficacy and Dose-Response of Intrathecal Dexmedetomidine in Attenuating Post-Spinal Shivering: Double-Blinded Randomized Controlled Trial
Overview
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.
Interventions
- Drug 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 - Drug 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. - Drug 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. - Drug 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.
Primary outcome measures
- Incidence of clinically significant shivering [Time frame: Throughout the intraoperative period until 60 minutes post-spinal.]
Secondary outcome measures (6)
- Time to first shivering episode [Time frame: Intraoperative period, up to 60 minutes post-spinal.]
- Requirement of rescue anti-shivering drug [Time frame: Intraoperative period, as needed.]
- Dose of rescue anti-shivering drug [Time frame: Intraoperative period, as needed.]
- Sedation level [Time frame: Postoperative 24 hour]
- Patient satisfaction [Time frame: Postoperatively (e.g., prior to discharge from PACU).]
- Time to first analgesic request [Time frame: 24 hours Postoperatively.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Al-Azhar University — Cairo
Identifiers
NCT: NCT07327879 · RC. 2.12.2025