Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section
NCT ID: NCT06318546
Last Updated: 2024-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
130 participants
INTERVENTIONAL
2024-04-01
2024-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Control
This group will undergo spinal anesthesia using fentanyl (50 microgram) as adjuvant to intrathecal bupivacaine
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%
Dexmedetomidine
This group will undergo spinal anesthesia using dexmedetomidine (10mg) as adjuvant to intrathecal bupivacaine
Dexmedetomidine Injection [Precedex],,,
patients will receive 0.5ml (10 µg) Dexmedetomidine as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5%
Interventions
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Dexmedetomidine Injection [Precedex],,,
patients will receive 0.5ml (10 µg) Dexmedetomidine as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5%
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%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 20-35 years.
* Height ≤165 cm.
* BMI ≤40.
* Procedure duration ≤ 90 minutes.
Exclusion Criteria
* 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.
20 Years
35 Years
FEMALE
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Principal Investigators
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Osama M Ragab, M.B.B.CH
Role: PRINCIPAL_INVESTIGATOR
Anesthesia resident Ain Shams University
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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Other Identifiers
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FMASU MS59/2024
Identifier Type: -
Identifier Source: org_study_id
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