Vaginal Hysterectomy Clinical Trial
Official title:
Sedation With Dexmedetomidine Versus Remifentanil in Urogynecological Surgery Under Spinal Anaesthesia : Impact on Block Characteristics, on Acute and Chronic Postoperative Pain
Neuraxial blocks are usually used as an anaesthetic method for urogynecological surgeries. In most patients under regional anaesthesia, premedication is given for reducing anxiety. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of dexmedetomidine vs remifentanil for sedation in patients under spinal anaesthesia for urogynecological procedures.
The day before surgery the procedure will be explained to the patient and the written consent
will be obtained. In the operating room, intraoperative monitoring will include ECG,
noninvasive blood pressure, oxygen saturation by pulse oximetry (SpO2) and heart rate (HR). A
peripheral intravenous catheter wil be placed for fluid replacement ( Ringer's Lactate
solution 6 - 8ml/ kg/hr) and administration of drugs.
Women will be randomly assigned into one of two groups:
Group A: Women will receive dexmedetomidine continuously infused at a dose of 0,6 mcg/kg for
10 minutes (concentration of the solution 6mcg/ml) before spinal anaesthesia. Infusion will
be stopped in order to proceed with regional anesthesia.
Group B: Women will receive remifentanil continuously infused at a dose of 1mcg/kg for 10
minutes (concentration of the solution 1mcg/ml) before spinal anaesthesia. Infusion will be
stopped in order to proceed with regional anesthesia.
The insertion of a 27 Gauge (27G) spinal needle is performed at L3-L4 or L4-L5 interspace, in
the lateral position. All patients will receive 2,7 ml ropivacaine 0,75% and 15 mcg fentanyl
intrathecally and assessment of sensory and motor block will be assessed every 2 min. The
moment that sensory block is in the highest dermatome and motor block is complete (Bromage
grade 3) is Time to max effect (Tmax). In group A an infusion of dexmedetomidine (6mcg/ml) at
a dose of 0,6mcg/kg/hr will be administered and in group B an infusion of remifentanil
(1mcg/ml) at a dose of 0,03 mcg/kg/min.At the end of the surgery patients will be transferred
in Post Anaesthetic Care Unit (PACU) and a patient control analgesia (PCA) pump will be
provided to the patient, administering 1 mg of morphine in every attempt, with a lock out
interval of 10 minutes.There will be no continuous infusion. All patients will receive a
standardized multimodal approach, including diclofenac 50 mg t.i.d, paracetamol 1gr as rescue
analgesia (max 4 gr per day) and PCA with morphine.
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