Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07327879

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Post-Spinal Shivering

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Al-Azhar University

Cairo, Egypt, 11865

Location contact

Hany Baumy, M.D

PRINCIPAL_INVESTIGATOR

Neveen A. Kohaf, PhD

CONTACT

[email protected]

01060383012

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Group P (Placebo Control Group)

Drug

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 intervention of the α2-adrenergic agonist.

Group D2.5 (Low-Dose Dexmedetomidine Group)

Drug

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.

Group D5 (Moderate-Dose Dexmedetomidine Group)

Drug

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.

Group D10 (Higher-Dose Dexmedetomidine Group)

Drug

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 outcomes

  1. Incidence of clinically significant shivering

    Time frame: Throughout the intraoperative period until 60 minutes post-spinal.

    Incidence of clinically significant shivering within 60 minutes after spinal injection, defined as Crossley and Mahajan shivering scale grade ≥2 (scale 0-4)The highest intensity of shivering experienced by the patient, scored on the 0-4 scale. The Crossley and Mahajan shivering scale is a clinically validated, four-grade ordinal scale (0-4) used to objectively quantify the severity of post-anesthetic shivering. It is defined as follows: Grade 0 signifies no shivering; Grade 1 indicates mild, intermittent fasciculations of the face, neck, or chest; Grade 2 represents visible, intermittent shivering involving more than one muscle group; Grade 3 denotes generalized, continuous shivering of the whole body; and Grade 4 describes gross, bed-shaking tremors that interfere with monitoring or procedure. Grade ≥2 is typically considered clinically significant and often triggers therapeutic intervention. The scale is assessed through direct visual observation of the patient by trained personnel.

Secondary outcomes

  1. Time to first shivering episode

    Time frame: Intraoperative period, up to 60 minutes post-spinal.

    The duration from the completion of the spinal injection to the onset of the first observable shivering (any grade).

  2. Requirement of rescue anti-shivering drug

    Time frame: Intraoperative period, as needed.

    the number of patients required pharmacologic intervention (meperidine or tramadol) to treat severe shivering.

  3. Dose of rescue anti-shivering drug

    Time frame: Intraoperative period, as needed.

    The total amount of pharmacologic intervention (meperidine or tramadol) to treat severe shivering.

  4. Sedation level

    Time frame: Postoperative 24 hour

    The Ramsey Sedation Scale (RSS) is a simple, widely used six-level clinical tool (scores 1-6) for assessing a patient's level of sedation and responsiveness. It is scored as follows: 1 - Patient is anxious, agitated, or restless; 2 - Patient is cooperative, oriented, and tranquil; 3 - Patient responds only to commands; 4 - Patient exhibits a brisk response to a light glabellar tap or loud auditory stimulus; 5 - Patient exhibits a sluggish response to such a stimulus; and 6 - Patient exhibits no response to stimulus.

  5. Patient satisfaction

    Time frame: Postoperatively (e.g., prior to discharge from PACU).

    The patient's overall satisfaction with the anesthesia experience.Using a Likert scale (e.g., 1-5 or 1-10) or a standardized satisfaction questionnaire.

  6. Time to first analgesic request

    Time frame: 24 hours Postoperatively.

    The duration from the end of surgery until the patient first requires supplemental pain medication.

Study contacts

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

Neveen A Kohaf, Ph.D

CONTACT

[email protected]

+201060383012

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • Benha University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.