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Could Ephedrine Replace Dexmedetomidine Fordexmedetomidine Prevention of Shivering in Women Undergoing Cesarean Section Under Spinal Anaesthesia

Could Ephedrine Replace Dexmedetomidine for Prevention of Shivering in Women Undergoing Cesarean Section Under Spinal Anaesthesia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06233032
Enrollment
200
Registered
2024-01-31
Start date
2024-02-10
Completion date
2025-09-01
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Shivering With Spinal Anaesthesia

Brief summary

Could ephedrine replace dexamedetomidine for prevention of shivering in women undergoing Cesarean section Under spinal anaesthesia

Detailed description

Shivering, rhythmic oscillatory movement of upper limbs, neck and jaw, is common during regional anesthesia with an incidence up to 56.7% of patients. Perioperative shivering is a commonly observed clinical problem well known to anesthesiologists caring for women undergoing a Cesarean delivery (CD). The median incidence of shivering in parturients having labour epidural analgesia or CD with epidural or spinal anesthesia has been estimated to be 52%.1 Severe shivering causes physiologic stress, interferes with patient monitors, and decreases the comfort and overall satisfaction of women during childbirth. Ephedrine well-known sympathomimetic agent, has been used to treat hypotension during regional anesthesia. It has antiemetic effect for short-term . Ephedrine maintained hemodynamics and minimized decrease of the core temperature when given by an intravenous infusion during spine surgery under general anesthesia . Dexmedetomidine, a selective a-2 agonist, was introduced in clinical practice in the United States in 1999. It is approved by Health Canada as a short-term sedative for mechanically ventilated adult patients in the intensive care unit and sedation of non-intubated patients prior to and/or during surgical procedures. It has since been approved and is widely used in pediatric populations and for procedural sedation of non-intubated patients.9 Nevertheless, the clinical use of dexmedetomidine has expanded to various off-label uses. In obstetrical anesthesia, it has been used as part of multi-modal intravenous labour and post-CD analgesia,10-13 as a neuraxial adjunct in the epidural space for labour,14 and intrathecally for shivering prevention during CD

Interventions

DRUGEphedrine

Patient Will receive 6mg IV

DRUGDexmedetomidine

Patient Will receive 30mcg IV

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult female from 18 to 35 yrs * uncomplicated pregnancy for elective cesarean delivery

Exclusion criteria

* patient refusal * allergy to the drug * contraindications of spinal anaesthesia * patients with DM or thyroid disorders

Design outcomes

Primary

MeasureTime frameDescription
Prevention of shivering during spinal anaesthesia in cesarean delivery .Intensity of shivering assessed using five point scale45minone hundred Pts will be included in this study . 1. fifty patients will receive Ephedrine 6 mg IV bolus before spinal block. 2. fifty patients will be receive 30 microgram IV bolus before spinal block

Countries

Egypt

Contacts

Primary ContactDina Salah Kamal, Master
dina14296@gmail.com01009196736
Backup ContactOla Mahmoud, Professor
01013046017

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026