A Phase 4 interventional study of Levobupivacaine and Dexmedetomidine in Perioperative/Postoperative Complications, sponsored by TC Erciyes University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-08-13.
Sponsored by TC Erciyes University · Phase 4, Interventional, and Prevention
The purpose of this study to compare the efficacy of intravenous or intrathecal dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for elective surgery.
The design of the study includes three study groups done in random order. The groups are as follows: 1) Control group received 15 mg levobupivacaine intrathecally and intravenous 0.9% sodium chloride; 2) Intravenous group received 15 mg levobupivacaine intrathecally and intravenous dexmedetomidine (1mcg/kg/10min, 0.5mcg/kg/h infusion) ; 3) Intrathecal group received 15 mg levobupivacaine + 3 mcg dexmedetomidine intrathecally and intravenous 0.9% sodium chloride.
Throughout the study period,shivering scores, tympanic temperature were recorded, heart rate were measured continuously using an electrocardiogram; blood pressure was determined oscillometrically at 5 min intervals at the ankle. In case heart rate decreased by more than 30% of the baseline atropin received and blood pressure decreased 30% of the baseline effedrin received.
Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting etc ) were recorded peroperatively in the operating room and postanesthetic care unit.
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's enrollment of 120 is close to the median of 119 across 689 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous dexmedetomidine (dexmedetomidine diluted 1mcg/ml and than 1ml/kg/10 minutes and 0.5 ml/kg/hour infusion)
Drug: Levobupivacaine · Drug: Dexmedetomidine · Drug: sodium chloride
Intrathecal (3 ml) 15 mg levobupivacaine + (0.3 ml) 3 mcg dexmedetomidine (dexmedetomidine diluted 10 mcg/ml) and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion)
Drug: Levobupivacaine · Drug: Dexmedetomidine · Drug: sodium chloride
Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion).
Drug: Levobupivacaine · Drug: sodium chloride
Intrathecal 3ml (15 mg)
Also known as: Chirocaine, 0.5%, 10 ml, Abbott
Intrathecal 3 microgram (diluted 1/10, 0.3 ml)
Also known as: Precedex, 100 mcg/ml, Abbott
Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion (dexmedetomidine diluted 1 microgram/ml)
Also known as: Precedex, 100 mcg/ml, Abbott
Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion in the control and intrathecal groups, intrathecal 0.3 ml in the control and intravenous groups.
Also known as: 0.9 Sodium chloride
shivering score
Time frame: 1 day (From start of anaesthesia till discharge from the recovery room )
blood pressure
non invasive blood pressure measured
Time frame: 1 day (From start of anaesthesia till discharge from the recovery room )
heart rate
Time frame: 1 day (From start of anaesthesia till discharge from the recovery room )
core temperature
lower than 36 celsius degree was accepted as hypothermia
Time frame: 1 day (From start of anaesthesia till discharge from the recovery room )
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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TC Erciyes University