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

Ain Shams University

Status: Enrolling

Conditions: Postoperative Analgesia; Intraoperative; Magnesium Sulfate; Ketamine; Rhinoplasty

Treatments: Drug: Ketamine and Magnesium Sulfate; Drug: Saline 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT06966518

36264PR1199/4/25

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

KM Group

Experimental group

Description:

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.

Treatment:

Drug: Ketamine and Magnesium Sulfate

Control group

Placebo Comparator group

Description:

Patients will receive saline 0.9% as a control group.

Treatment:

Drug: Saline 0.9%