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

A

Assiut University

Status

Enrolling

Conditions

Prevention of Shivering With Spinal Anaesthesia

Treatments

Drug: Dexmedetomidine
Drug: Ephedrine

Study type

Interventional

Funder types

Other

Identifiers

NCT06233032
Prevention of shivering

Details and patient eligibility

About

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

Full 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

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Group E
Experimental group
Treatment:
Drug: Ephedrine
Group D
Experimental group
Treatment:
Drug: Dexmedetomidine

Trial contacts and locations

1

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Central trial contact

Ola Mahmoud, Professor; Dina Salah Kamal, Master

Data sourced from clinicaltrials.gov

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