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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

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06427707
Enrollment
90
Registered
2024-05-24
Start date
2024-06-15
Completion date
2024-10-31
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Bleeding

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.

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

DRUGIntravenous 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

DRUGIntravenous 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.

DRUGIntravenous 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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
surgical field using the average category scale (ACS).During the operationDegree of surgical field bleeding

Secondary

MeasureTime frameDescription
sedation using Ramsy sedation scoreFirst hour postoperativeDegree of sedation using Ramsy sedation score

Countries

Egypt

Contacts

Primary ContactRANIA M Hussien, MD
drrania_maamon@med.asu.edu.eg01000544520
Backup ContactFathy Tash, MD
REC-FMASU@med.asu.edu.eg26857539

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026