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Clinical trial

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

ID
Name
FMASU MS59/2024
Description
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
Trial arms
Trial start
2024-06-01
Estimated PCD
2024-10-01
Trial end
2024-11-01
Status
Not yet recruiting
Treatment
Dexmedetomidine Injection [Precedex],,,
patients will receive 0.5ml (10 µg) Dexmedetomidine as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5%
Arms:
Dexmedetomidine
Other names:
Precedex
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%
Arms:
Control
Size
60
Primary endpoint
Post spinal shivering
From injection to 3 hours post operative
Eligibility criteria
Inclusion Criteria: * • ASA I or ASA II patients Scheduled for CS under spinal anaesthesia. * Age 20-35 years. * Height ≤165 cm. * BMI ≤40. * Procedure duration ≤ 90 minutes. Exclusion Criteria: * • Patients with known neurologic and psychiatric illness. * Contraindications for spinal anaesthesia as patient refusal, bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia. * Spine abnormalities. * Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency. * Allergy to any of the drugs used in the study. * Toxemia of pregnancy or hypertension with pregnancy.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-06-04

1 organization

2 products

1 indication

Organization
Ain Shams University
Product
Dexmedetomidine
Indication
Post Spinal Shivering
Product
Fentanyl