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

NCT06966102 | Not Yet Recruiting Phase 4

• 1 other identifier: MS-15-2025
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• intraoperative fentanyl consumption

  total fentanyl consumption during surgery

  for 5 hours starting from induction of general anesthesia

Secondary Outcomes (4)

• intraoperative mean arterial blood pressure

  for 5 hours starting from induction of general anesthesia

• Intraoperative heart rate

  for 5 hours starting from induction of general anesthesia

• Clarity of the surgical field

  for 5 hours starting from induction of general anesthesia

• Surgeon satisfaction

  for 5 hours starting from induction of general anesthesia

Study Arms (3)

Group L

ACTIVE COMPARATOR

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

Drug: Lidocaine group

Group M

ACTIVE COMPARATOR

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

Drug: Magnesium group

Group C

SHAM COMPARATOR

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

Drug: Control group

Interventions

Lidocaine group 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 L

Magnesium group 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 M

Control group 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

Group C

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jehan Elkholy, M.D.

  Cairo University

  STUDY CHAIR

• Kareem MA Nawwar, M.D.

  Cairo University

  STUDY DIRECTOR

• Dina M Mohamed, M.D.

  Cairo University

  STUDY DIRECTOR

• Dalia G Abdel Nasser, M.B.B.Ch.

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kareem MA Nawwar, M.D.

CONTACT

+201003878369; drknawwar@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 11, 2025
• Study Start: May 10, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 30, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

EG (1)