Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06966518

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Intraoperative Ketamine Magnesium Sulfate Postoperative Analgesia Rhinoplasty

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11591, Egypt

Location status: Recruiting

Location contact

Maram I Elmazny, MD

PRINCIPAL_INVESTIGATOR

Sarah A Afifi, MD

CONTACT

[email protected]

0501035864

Sondos Ahmed, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Total morphine consumption

    Time frame: 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 outcomes

  1. Time to the 1st rescue analgesia.

    Time frame: 24 hours postoperatively

    Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).

  2. Degree of pain

    Time frame: 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.

  3. Heart rate

    Time frame: Till the end of surgery (Up to 2 hours)

    Heart rate will be recorded preoperatively and every 15 minutes till the end of surgery.

  4. Mean arterial pressure

    Time frame: 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.

  5. Degree of patient satisfaction

    Time frame: 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)

  6. Incidence of adverse events.

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, hallucinations, nightmares, blurred vision, dizziness or any other complication.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah A Afifi, MD

CONTACT

[email protected]

0501035864

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effectiveness of Intraoperative Combination of Ketamine and Magnesium Sulfate Infusions on Postoperative Analgesia in Patients Undergoing Open Rhinoplasty: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 12, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.