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Recruiting NCT06427707

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

Phase II / Phase III Interventional Intraoperative Bleeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravenous Infusion of propofol, lidocaine, Magnesium sulfate, Intravenous infusion of ketamine, lidocaine, Magnesium sulfate, Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate.
Who it may be relevant to
Registry conditions: Intraoperative Bleeding. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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

Interventions

  • 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
  • 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.
  • 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

Primary outcome measures

  • surgical field using the average category scale (ACS). [Time frame: During the operation]
Secondary outcome measures (1)
  • sedation using Ramsy sedation score [Time frame: First hour postoperative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Identifiers

NCT: NCT06427707 · FMASU R84/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗