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

NCT ID: NCT06233032

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-10
• Study Completion Date: 2025-09-01

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

Conditions

Prevention of Shivering With Spinal Anaesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group E

Group Type: EXPERIMENTAL

Ephedrine

Intervention Type: DRUG

Patient Will receive 6mg IV

Group D

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Patient Will receive 30mcg IV

Interventions

Ephedrine

Patient Will receive 6mg IV

Intervention Type: DRUG

Dexmedetomidine

Patient Will receive 30mcg IV

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Dina Salah Kamal Salman

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina Salah Kamal, Master

Role: CONTACT

dina14296@gmail.com

01009196736

Ola Mahmoud, Professor

Role: CONTACT

01013046017

Facility Contacts

Assiut university

Role: primary

Vp_grad@aun.edu.eg

+209922080150

Other Identifiers

Prevention of shivering

Identifier Type: -

Identifier Source: org_study_id