The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions in Nasal Surgeries.

The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions As an Opioid Free Anaesthesia on Surgical Field in Patients Undergoing Nasal Surgeries. a Randomized Controlled Trial

Nasal surgeries are common day case procedures. Although surgical complications are rare, bleeding decreases surgical field visibility and may cause vascular, orbital or intracranial complications in addition to failure of procedure. So, it is crucial to maintain hypotensive anaesthesia to optimize the surgical field.

Study Overview

• Status: Recruiting
• Conditions: Intraoperative Bleeding
• Intervention / Treatment: Drug: Intravenous Infusion of propofol, lidocaine, Magnesium sulfate; Drug: Intravenous infusion of ketamine, lidocaine, Magnesium sulfate; Drug: Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate

Detailed Description

In this study the investigators compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality, intraoperative haemodynamics, surgical time, recovery time, sedation score, time to first rescue analgesic and incidence of PONV in patients undergoing nasal surgeries

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Rania M Hussien, MD; Phone Number: 202 01000544520; Email: drrania_maamon@med.asu.edu.eg
• Study Contact Backup: Name: Fathy Tash, MD; Phone Number: 202 26857539; Email: REC-FMASU@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 69711
    • Recruiting
    • Ain shams university
    • Contact: Rania M Hussien, MD; Phone Number: 202 026213948; Email: drrania_maamon@med.asu.edu.eg
    • Contact: Hala S El Ozairy, MD; Phone Number: 202 01001191199; Email: hala_elozairy@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA I-II,
• scheduled for elective nasal surgery

Exclusion Criteria:

• Patients with uncontrolled hypertension.
• Patients with cardiac disease.
• Patients with renal, hepatic or cerebral insufficiency.
• Patients with coagulopathy or receiving drugs influencing blood coagulation.
• Anaemia, haemoglobinopathies or polycythemia.
• Pregnancy.
• Patients with known sensitivity to any of the study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group PLM (propofol-lidocaine-magnesium); intravenous infusion of propofol, lidocaine and magnesium sulfate.	Drug: Intravenous Infusion of propofol, lidocaine, Magnesium sulfate; intravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. the effect of either Propofol injection, or ketamine injection or dexmeditomidine injection on intraoperative bleeding
Active Comparator: Group KLM (ketamine-lidocaine-magnesium); intravenous infusion of Ketamine, lidocaine and magnesium sulfate	Drug: Intravenous infusion of ketamine, lidocaine, Magnesium sulfate; Patients will receive intravenous infusion of Ketamine 0.1-0.2 mg.kg-1.h-1 (intravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. dose of 1 mg.kg-1), lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1.
Active Comparator: Group DLM (Dexmeditomidine-lidocaine-magnesium); Intravenous infusion of Dexmeditomidine, lidocaine and magnesium sulfate	Drug: Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate; Dexmeditomidine (Precedex® 200 mcg.2ml-1) with a rate of 0.2-0.6 mcg.Kg-1.h-1. lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical field using the average category scale (ACS).	Degree of surgical field bleeding	During the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sedation using Ramsy sedation score	Degree of sedation using Ramsy sedation score	First hour postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 5, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Anticonvulsants; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Ketamine; Propofol; Dexmedetomidine; Lidocaine; Magnesium Sulfate
• Other Study ID Numbers: FMASU R84/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No