The study aims to evaluate the effectiveness of intraoperative combination of ketamine and magnesium sulfate infusions on postoperative analgesia in patients undergoing open rhinoplasty.
Postoperative pain remains one of the most crucial factors affecting patient satisfaction. These symptoms can be distressing for the patient and it may lead to negative psychological implications. Ketamine is a non-competitive N-Methyl D-Aspartate (NMDA) receptor antagonist that works by blocking the NMDA receptors in the central and peripheral nervous systems. Magnesium sulfate is also an antagonist for NMDA receptor that has been evaluated in several studies and showed that Mg sulfate decreased consumption of postoperative opioids. Ketamine and magnesium sulfate have different sites of action on NMDA receptors, so their combination may produce a synergistic effect on NMDA receptors, resulting in more control of postoperative pain and more sparing of consumption of opioids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Patients will receive a bolus of 0.5 mg/kg of ketamine given over a period of ten minutes followed by a constant infusion of 0.25 mg/kg/hr and a bolus dose of 30 mg/kg of magnesium sulfate during a 10-minute period followed by a continuous infusion of 9 mg/kg/hr.
Patients will receive saline 0.9% as a control group.
Ain Shams University
Cairo, Egypt
RECRUITINGTotal morphine consumption
Rescue analgesia of morphine will be given as a 3 mg bolus if the numeric rating scale (NRS) \> 3, to be repeated after 30 min if pain persists until the NRS \< 4.
Time frame: 24 hours postoperatively
Time to the 1st rescue analgesia.
Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).
Time frame: 24 hours postoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 4, 6, 8, 12, 18, and 24 h postoperatively.
Time frame: 24 hours postoperatively
Heart rate
Heart rate will be recorded preoperatively and every 15 minutes till the end of surgery.
Time frame: Till the end of surgery (Up to 2 hours)
Mean arterial pressure
Mean arterial pressure will be recorded preoperatively and every 15 minutes till the end of surgery.
Time frame: Till the end of surgery (Up to 2 hours)
Degree of patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Time frame: 24 hours postoperatively
Incidence of adverse events.
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, hallucinations, nightmares, blurred vision, dizziness or any other complication.
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Time frame: 24 hours postoperatively