Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06966518

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

Led by Ain Shams University · Updated on 2025-05-13

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate how well a combination of ketamine and magnesium sulfate infusions during surgery controls pain after open rhinoplasty. The study focuses on managing postoperative pain, which is important for patient comfort and satisfaction. Both ketamine and magnesium sulfate target NMDA receptors but act differently, so their combined use may better control pain and reduce the need for opioid painkillers. Participants in the study will receive either a combination of ketamine and magnesium sulfate or a saline placebo during their rhinoplasty surgery. The ketamine dose includes a bolus followed by a constant infusion, while magnesium sulfate is given as a bolus and then a continuous infusion. The control group receives saline infusions. This comparison aims to assess the pain relief effects of the combined drugs during and after surgery. During the study, researchers will monitor total morphine use within 24 hours after surgery, time until first rescue pain medication, pain levels, heart rate, blood pressure, patient satisfaction, and any side effects. Monitoring occurs up to 24 hours postoperatively with heart rate and blood pressure tracked during surgery. The trial will help understand how this drug combination affects pain control and opioid use after rhinoplasty.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age from 18 to 65 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I - II.
  • Scheduled for rhinoplasty under general anesthesia.
Not Eligible

You will not qualify if you...

  • Receiving analgesic or any medications within 48 hours before surgery.
  • Drug addiction.
  • Cardiovascular disease.
  • Respiratory, renal, liver, metabolic, or neurological disease.
  • Pregnancy or breastfeeding.
  • Asthma.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 hours (duration of surgery)

Participants receive intraoperative infusions of ketamine and magnesium sulfate or saline during open rhinoplasty surgery to manage postoperative pain.

1 visit (in-person surgery day)

Post-operative Follow-up

Duration - 24 hours postoperatively

Participants are monitored for pain control, opioid consumption, vital signs, and any adverse events for 24 hours after surgery.

Approximately 1 follow-up visit within 24 hours

Trial Site Locations

Total: 1 location

1

Ain Shams University

Cairo, Egypt, 11591

Actively Recruiting

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Research Team

S

Sarah A Afifi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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