Suez Canal University
Ismailia, Egypt
NCT Number: NCT04374318
A prospective, randomized, comparative controlled clinical trial, aiming to compare the use of intrathecal dexmedetomidine by intravenous dexmedetomidine in concern of the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Ismailia, Egypt
Seventy patients undergoing lower limb surgeries were included in this study. Using a random number sequence, patients were enrolled in one of two groups: Group T receiving 5 µg of dexmedetomidine (Precedex® 100 µg/mL, Hospira, Inc., IL, U.S.A.) combined with 12.5 mg of 0.5% hyperbaric bupivacaine (Marcaine® Spinal Heavy; Astra, Sodertalje, Sweden) and Group V receiving the same bupivacaine DOSE AND 0.75 microgram/kilogram of body weight dexmedetomidine intravenously. Dexmedetomidine 100 µg/mL was mixed with preservative-free normal saline to 10 µg/mL. The 0.5 mL of dilute dexmedetomidine was added to the bupivacaine in group T. An independent investigator prepared the drug solutions and provided the coded drug to the anaesthetic administrator before the start of the anaesthesia. The anaesthetic administrator, patients, outcome assessors, and data analysts were blinded to the allocation. Spinal Anesthesia Patients were hydrated with 500 mL of 0.9% sodium chloride solution before anaesthesia. The spinal puncture was performed at L3-4 or L4-5 with a midline approach using a 25 G Quincke needle in the lateral decubitus position. After confirmation of free flow and clear cerebrospinal fluid, the drug was administered and the patients were then placed in the supine neutral position.
Assessment: The primary end-point of this study was the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
INTRATHECAL AND INTRAVENOUS
Other names: precidex
Time frame: Postoperative up to 24 hours
The first time the patient is asking for analgesia to control his pain
Time frame: Postoperative up to 24 hours
Total consumption of analgesia to control pain
Time frame: Every two hours for 24 hours postoperative
The score subjectively measures the severity of pain and it is ranging from 0 when there is no pain to 10 when it is the worse pain imaginable
Suez Canal University
Other
Comparison Study Between Intrathecal and Intravenous Dexmedetomidine in Lower Limb Surgeries
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