Intraoperative Combination of Ketamine and Magnesium Sulfate Infusions on Postoperative Analgesia in Open Rhinoplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketamine and Magnesium Sulfate, Saline 0.9%.
- Who it may be relevant to
- Registry conditions: Intraoperative, Ketamine, Magnesium Sulfate, Postoperative Analgesia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effectiveness of Intraoperative Combination of Ketamine and Magnesium Sulfate Infusions on Postoperative Analgesia in Patients Undergoing Open Rhinoplasty: A Randomized Controlled Trial
Overview
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
- Drug 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. - Drug Saline 0.9%
Patients will receive saline 0.9% as a control group.
Primary outcome measures
- Total morphine consumption [Time frame: 24 hours postoperatively]
Secondary outcome measures (6)
- Time to the 1st rescue analgesia. [Time frame: 24 hours postoperatively]
- Degree of pain [Time frame: 24 hours postoperatively]
- Heart rate [Time frame: Till the end of surgery (Up to 2 hours)]
- Mean arterial pressure [Time frame: Till the end of surgery (Up to 2 hours)]
- Degree of patient satisfaction [Time frame: 24 hours postoperatively]
- Incidence of adverse events. [Time frame: 24 hours postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Ain Shams University — Cairo
Identifiers
NCT: NCT06966518 · 36264PR1199/4/25