Postoperative Analgesia Clinical Trial
Official title:
Comparison Study Between Intrathecal and Intravenous Dexmedetomidine in Lower Limb Surgeries
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.
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.
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