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

NCT06427707 | Recruiting Phase 2

• 1 other identifier: FMASU R84/2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraoperative Bleeding

Outcome Measures

Primary Outcomes (1)

• surgical field using the average category scale (ACS).

  Degree of surgical field bleeding

  During the operation

Secondary Outcomes (1)

• sedation using Ramsy sedation score

  First hour postoperative

Study Arms (3)

Group PLM (propofol-lidocaine-magnesium)

ACTIVE COMPARATOR

intravenous infusion of propofol, lidocaine and magnesium sulfate.

Drug: Intravenous Infusion of propofol, lidocaine, Magnesium sulfate

Group KLM (ketamine-lidocaine-magnesium)

ACTIVE COMPARATOR

intravenous infusion of Ketamine, lidocaine and magnesium sulfate

Drug: Intravenous infusion of ketamine, lidocaine, Magnesium sulfate

Group DLM (Dexmeditomidine-lidocaine-magnesium)

ACTIVE COMPARATOR

Intravenous infusion of Dexmeditomidine, lidocaine and magnesium sulfate

Drug: Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate

Interventions

Intravenous Infusion of propofol, lidocaine, Magnesium sulfate DRUG

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

Group PLM (propofol-lidocaine-magnesium)

Intravenous infusion of ketamine, lidocaine, Magnesium sulfate DRUG

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.

Group KLM (ketamine-lidocaine-magnesium)

Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate DRUG

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

Also known as: Precedex

Group DLM (Dexmeditomidine-lidocaine-magnesium)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 69711, Egypt

RECRUITING

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Lidocaine; Magnesium Sulfate; Dexmedetomidine

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

RANIA M Hussien, MD

CONTACT

01000544520; drrania_maamon@med.asu.edu.eg

Fathy Tash, MD

CONTACT

26857539; REC-FMASU@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality in patients undergoing nasal surgeries.

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: June 15, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

EG (1)