About this trial
The current work evaluated whether the combination of intrathecal dexmedetomidine and fentanyl provides superior postoperative analgesia to fentanyl alone when administered with hyperbaric bupivacaine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age from 18 to 60 years.
Both sexes.
American Society of Anesthesiologists (ASA) physical status of II-III.
Height between 150-185 cm.
Disqualifiers
Allergy to any of the investigated drugs.
History of heart block, arrhythmia, or ongoing therapy with beta- or calcium channel- blockers, or angiotensin-converting-enzyme inhibitors.
Contraindications to spinal anesthesia.
Pregnancy or lactation.
Trial design
Parallel
Treatments tested in this trial
Fentanyl + Dexmedetomidine
DrugPatients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.
Fentanyl
DrugPatients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.
Treatment groups
Trial outcomes
Primary outcomes
Time to first rescue analgesia
Time to first rescue analgesia (time from the end of surgery till the first dose of morphine is administered).
Secondary outcomes
Total amount of morphine
If the Visual Analogue Scale (VAS) exceeded 3, rescue analgesia (RA) will be administered with intravenous morphine 3 mg.
Intraoperative fentanyl consumption
Additional fentanyl bolus dosages of 0.5 µg/kg IV will be administered if heart rate or mean arterial blood pressure is elevated more than 20% of the baseline (after exclusion of other causes than pain).
Degree of pain
Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at the Post-Anesthesia Care Unit (PACU), 2, 4, 6, 12, 18, and 24 h postoperatively.
Incidence of adverse events
Incidence of adverse events such as Nausea and vomiting, shivering, bradycardia, hypotension, and respiratory depression were recorded.
Sponsors and contacts
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