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Intraoperative Combination of Ketamine and Magnesium Sulfate Infusions on Postoperative Analgesia in Open Rhinoplasty

ConditionsIntraoperativeKetamineMagnesium SulfatePostoperative AnalgesiaRhinoplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAin Shams University

About this trial

The study aims to evaluate the effectiveness of intraoperative combination of ketamine and magnesium sulfate infusions on postoperative analgesia in patients undergoing open rhinoplasty.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 65 years.

Both sexes.

American Society of Anesthesiologists (ASA) physical status I - II.

Scheduled for rhinoplasty under general anesthesia.

Disqualifiers

Receiving analgesic or any medications since 48 hours before the surgery.

Drug addiction.

Cardiovascular disease.

Respiratory disease, renal, liver, metabolic and neurological disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketamine and Magnesium Sulfate

    Drug

    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.

  • Saline 0.9%

    Drug

    Patients will receive saline 0.9% as a control group.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: KM GroupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total 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

Secondary outcomes

1

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
2

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
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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