Intraoperative, Ketamine, Magnesium Sulfate, Postoperative Analgesia, Rhinoplasty
Conditions
Brief summary
The study aims to evaluate the effectiveness of intraoperative combination of ketamine and magnesium sulfate infusions on postoperative analgesia in patients undergoing open rhinoplasty.
Detailed description
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.
Interventions
DRUGKetamine and Magnesium Sulfate
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.
DRUGSaline 0.9%
Patients will receive saline 0.9% as a control group.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 65 years. * Both sexes. * American Society of Anesthesiologists (ASA) physical status I - II. * Scheduled for rhinoplasty under general anesthesia.
Exclusion criteria
* Receiving analgesic or any medications since 48 hours before the surgery. * Drug addiction. * Cardiovascular disease. * Respiratory disease, renal, liver, metabolic and neurological disease. * Pregnancy or breast feeding. * Asthma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | 24 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 24 hours postoperatively | 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. |
| Heart rate | Till the end of surgery (Up to 2 hours) | Heart rate will be recorded preoperatively and every 15 minutes till the end of surgery. |
| Time to the 1st rescue analgesia. | 24 hours postoperatively | Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated). |
| Degree of patient satisfaction | 24 hours postoperatively | 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) |
| Incidence of adverse events. | 24 hours postoperatively | Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, hallucinations, nightmares, blurred vision, dizziness or any other complication. |
| Mean arterial pressure | Till the end of surgery (Up to 2 hours) | Mean arterial pressure will be recorded preoperatively and every 15 minutes till the end of surgery. |
Countries
Egypt
Contacts
Primary ContactSarah A Afifi, MD
Outcome results
None listed