Ain Shams University
Cairo, Abbassia, 00202, Egypt
NCT Number: NCT06502262
The aim of this study is to compare the addition of intrathecal dexmedetomidine or fentanyl as adjuvants to hyperbaric bupivacaine in the onset and duration of sensory and motor block, and postoperative analgesia.
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Notify Me21 year–55 year
All sexes
Interventional
Phase 1
Cairo, Abbassia, 00202, Egypt
The aim of this study is to compare the addition of intrathecal dexmedetomidine or fentanyl as adjuvants to hyperbaric bupivacaine in the onset and duration of sensory and motor block, and postoperative analgesia. 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. 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 anesthesia and maintenance volume of 10ml\\kg.
For each group, patients will be put in sitting position, lumbar puncture will be performed under complete aseptic precautions, local anesthesia 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patient will be given 3ml (15mg) of 0.5% hyperbaric bupivacaine + 0.5 ml of normal saline intrathecally.
patients will be given 3ml (15mg) of 0.5%hyperbaric bupivacaine +0.5ml (25 microgram) of fentanyl intrathecally
patient will receive 3ml (15mg) of .05 hyperbaric bupivacaine 0.5ml(5 microgram) of diluted dexmedetomidine intrathecally
Other names: precedex
Time frame: from injection up to Modified Bromage score 1 ( 5 minutes)
Onset of motor block (defined as time in minutes from the end of drug injection intrathecally until patient is unable to move the hip, knee, and ankle)
Time frame: from injection up to s1 regression ( 5 minutes)
defined as time in minutes to reach highest sensory level) will be tested every minute after intrathecal injection until it reach the highest level. It will be assessed by pin prick and cold application
Time frame: from injection up to 24 hours post operative
will be evaluated using a visual analog scale (VAS),
Time frame: from injection up to 24 hours post operative
using non invasive arterial blood pressure monitoring
Time frame: from injection up to24hours post operative
using pulse oximiter
Time frame: from injection up to 24 hours post operative
using ecg monitoring
Ain Shams University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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