MedTrace Logo

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

NCT07327879 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-08

No results posted yet for this study

Summary

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.

Conditions

  • 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 intervention of the α2-adrenergic agonist.

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.

Sponsors & Collaborators

  • Benha University

    collaborator OTHER

  • Al-Azhar University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-28
Primary Completion
2026-11-30
Completion
2026-12-30

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07327879 on ClinicalTrials.gov