Lidocaine Infusion Versus Magnesium Infusion in Decreasing Fentanyl Requirements in Endoscopic Sinus Surgeries

May 3, 2025 updated by: Kareem Mohammed Assem Nawwar, Cairo University

Evaluating the Effect of Lidocaine Infusion Versus Magnesium Sulfate Infusion on Decreasing Total Fentanyl Requirements in Patients Undergoing Functional Endoscopic Sinus Surgeries: a Randomized Controlled Study

Enhanced recovery after ear, nose and throat surgery is based on multimodal and multidisciplinary perioperative interventions to decrease postoperative pain. Functional endoscopic sinus surgery is a surgical management for chronic rhinosinusitis. Although a common procedure, there is a lack of knowledge about perioperative pain and specific pain management after such a procedure. Most of recommendations given in guidelines for postoperative pain management in nasal surgery and sinus surgery are subsumed under head and neck surgery. Head and neck surgery is a wide field covering widely variable surgical procedures. So, postoperative pain management guidelines may not meet the requirements for pain management during and after endoscopic sinus surgery.

Various medications have been used to improve the surgical field and postoperative pain including intravenous clonidine, dexmedetomidine, lidocaine, and magnesium.

Lidocaine has been used considering its analgesic, immuno-modulating, and anti-inflammatory properties. The opioid sparing effect of lidocaine is supported by a high level of evidence. The effectiveness of lidocaine infusion in obtaining reduction of postoperative pain, gastrointestinal recovery time, postoperative nausea and vomiting, and shortening the hospital length of stay, was demonstrated principally in major gastro-intestinal surgery.

Magnesium sulfate is a good option in multimodal analgesia, as it stabilizes the cell membrane and intracytoplasmic organelles by mediating the activation of Na+-K+ ATPase and Ca++ ATPase enzymes, which have an important role in transmembrane ion exchange during the depolarization and repolarization phases. Moreover, magnesium inhibits the release of norepinephrine by blocking the N-type Ca++ channels at nerve endings.

Many studies were designed to prove the role of the analgesic effect of lidocaine and magnesium infusion. However, this is the first randomized controlled study to assess the effect of lidocaine infusion versus magnesium sulphate infusion on decreasing total fentanyl requirements in patients undergoing functional endoscopic sinus surgery.

This randomized controlled trial was designed to compare the efficacy of lidocaine hydrochloride infusion versus magnesium sulphate infusion in controlling perioperative pain in patients undergoing functional endoscopic sinus surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of medicine, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age from 21 to 60 years.
  • Both genders.
  • American society of Anesthesiologist (ASA) physical status I-II
  • Scheduled for functional endoscopic sinus surgery under general anesthesia.

Exclusion Criteria:

  • Patients with prolonged QT interval.
  • Patients with renal disease.
  • Patients with a history of allergy to lidocaine or magnesium sulfate.
  • American Society of Anesthesiologists class higher than II.
  • Patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group L
Patients received 2 mg/kg/h lidocaine hydrocloride starting at induction of anesthesia and continuing until the end of surgery
Drug: Lidocaine group
25ml of lidocaine hydrochloride 2% will be added to 25 ml of standard saline 0.9% solution in a 50ml syringe to be infused via a syringe pump. The resultant concentration will be 10mg/ml. According to the calculated study drug dose, each patient will receive 0.2ml/kg/h
Active Comparator: Group M
Patients received magnesium sulphate 20 mg/kg/h starting at induction of anesthesia and continuing until the end of surgery
Drug: Magnesium group
a 50ml syringe will be filled with magnesium sulfate solution (100mg/ml) to be infused via a syringe pump. According to the calculated study drug dose, each patient will receive 0.2ml/kg/h
Sham Comparator: Group C
Patients received saline infusion starting at induction of anesthesia and continuing until the end of surgery
Drug: Control group
a 50ml syringe will be filled with a standard saline 0.9% solution to be infused via a syringe pump. Each patient will receive 0.2ml/kg/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative fentanyl consumption
Time Frame: for 5 hours starting from induction of general anesthesia
total fentanyl consumption during surgery
for 5 hours starting from induction of general anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative mean arterial blood pressure
Time Frame: for 5 hours starting from induction of general anesthesia
mean arterial blood pressure during surgery
for 5 hours starting from induction of general anesthesia
Intraoperative heart rate
Time Frame: for 5 hours starting from induction of general anesthesia
heart rate during surgery
for 5 hours starting from induction of general anesthesia
Clarity of the surgical field
Time Frame: for 5 hours starting from induction of general anesthesia
Clarity of the surgical field according to Fromme and Boezaart scale (grade 0 means no bleeding and grade 5 means High bleeding, so constant blood evacuation is needed)
for 5 hours starting from induction of general anesthesia
Surgeon satisfaction
Time Frame: for 5 hours starting from induction of general anesthesia
Surgeon satisfaction assessed at the end of the operation on a 5-point Likert satisfaction scale (grade 1 means Extremely dissatisfied and grade 5 means Extremely satisfied)
for 5 hours starting from induction of general anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Jehan Elkholy, M.D., Cairo University
  • Study Director: Kareem MA Nawwar, M.D., Cairo University
  • Study Director: Dina M Mohamed, M.D., Cairo University
  • Principal Investigator: Dalia G Abdel Nasser, M.B.B.Ch., Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2025

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

May 3, 2025

First Submitted That Met QC Criteria

May 3, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 3, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-15-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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