NCT06318546

Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section

Efficacy of Dexmedetomidine As Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post Spinal Shivering in Parturients Undergoing Caesarean Section

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The investigators will test the effects of intrathecal dexmedetomidine as adjuvant to intrathecal bupivacaine and it's direct effect in decreasing incidence of post spinal shivering in Parturients Undergoing Caesarean section

Detailed description

A.Preoperative settings: All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery. B.Intraoperative and postoperative settings: On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anaesthesia and maintenance volume of 10ml\\kg. For each group, patients will be put in sitting position, the procedure will be performed under complete aseptic precautions, local anaesthesia will be administered by infiltration of the skin and subcutaneous tissues with 3-5 ml lidocaine 1% at L3-L4 and A 25-G needle will be used. Both groups will be given 2.2ml {11-12 mg} hyperbaric Bupivacaine hydrochloride 0.5%

Conditions

• Post Spinal Shivering

Interventions

Type	Name	Description
DRUG	Dexmedetomidine Injection [Precedex],,,	patients will receive 0.5ml (10 µg) Dexmedetomidine as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5%
DRUG	Fentanyl	will be given 0.5 ml of one ampoule (2ml) of 100µg fentanyl (Fentanyl Hameln® 0.1mg/2ml - Sunny pharm) equivalent to 25 µg fentanyl as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5%

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2024-03-19
• Last updated: 2024-11-05

Locations

1 site across 1 country: Egypt