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

NCT ID: NCT06966102

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-10
• Study Completion Date: 2025-07-30

Brief Summary

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.

Conditions

Enhanced Recovery; Functional Endoscopic Sinus Surgery; Lidocaine; Magnesium Sulphate; Perioperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Group L

Patients received 2 mg/kg/h lidocaine hydrocloride starting at induction of anesthesia and continuing until the end of surgery

Group Type: ACTIVE_COMPARATOR

Lidocaine group

Intervention Type: DRUG

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

Group M

Patients received magnesium sulphate 20 mg/kg/h starting at induction of anesthesia and continuing until the end of surgery

Group Type: ACTIVE_COMPARATOR

Magnesium group

Intervention Type: DRUG

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

Group C

Patients received saline infusion starting at induction of anesthesia and continuing until the end of surgery

Group Type: SHAM_COMPARATOR

Control group

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Kareem Mohammed Assem Nawwar

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jehan Elkholy, M.D.

Role: STUDY_CHAIR

Cairo University

Kareem MA Nawwar, M.D.

Role: STUDY_DIRECTOR

Cairo University

Dina M Mohamed, M.D.

Role: STUDY_DIRECTOR

Cairo University

Dalia G Abdel Nasser, M.B.B.Ch.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Medicine, Cairo University

Cairo, , Egypt

Countries

Egypt

Central Contacts

Kareem MA Nawwar, M.D.

Role: CONTACT

drknawwar@cu.edu.eg

+201003878369

Other Identifiers

MS-15-2025

Identifier Type: -

Identifier Source: org_study_id