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

Not Applicable

Recruiting

• Conditions: Intraoperative; Ketamine; Magnesium Sulfate; Postoperative Analgesia; Rhinoplasty
• Interventions: Drug: Ketamine and Magnesium Sulfate; Drug: Saline 0.9%

• Registration Number: NCT06966518
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-04
• Study First Submitted QC: 2025-05-04
• Study Start: 2025-05-12
• Study First Posted: 2025-05-12
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KM Group	Ketamine 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.
Control group	Saline 0.9%	Patients will receive saline 0.9% as a control group.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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.
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.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt