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

A

Ain Shams University

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Intraoperative Bleeding

Treatments

Drug: Intravenous infusion of ketamine, lidocaine, Magnesium sulfate
Drug: Intravenous Infusion of propofol, lidocaine, Magnesium sulfate
Drug: Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate

Study type

Interventional

Funder types

Other

Identifiers

NCT06427707
FMASU R84/2024

Details and patient eligibility

About

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.

Full 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

Enrollment

90 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 3 patient groups

Group PLM (propofol-lidocaine-magnesium)
Active Comparator group
Description:
intravenous infusion of propofol, lidocaine and magnesium sulfate.
Treatment:
Drug: Intravenous Infusion of propofol, lidocaine, Magnesium sulfate
Group KLM (ketamine-lidocaine-magnesium)
Active Comparator group
Description:
intravenous infusion of Ketamine, lidocaine and magnesium sulfate
Treatment:
Drug: Intravenous infusion of ketamine, lidocaine, Magnesium sulfate
Group DLM (Dexmeditomidine-lidocaine-magnesium)
Active Comparator group
Description:
Intravenous infusion of Dexmeditomidine, lidocaine and magnesium sulfate
Treatment:
Drug: Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate

Trial contacts and locations

1

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Central trial contact

RANIA M Hussien, MD; Fathy Tash, MD

Data sourced from clinicaltrials.gov

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