Clinical trial
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
Name
FMASU R84/2024
Description
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.
Trial arms
Trial start
2024-06-15
Estimated PCD
2024-10-01
Trial end
2024-10-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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
Arms:
Group PLM (propofol-lidocaine-magnesium)
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.
Arms:
Group KLM (ketamine-lidocaine-magnesium)
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
Arms:
Group DLM (Dexmeditomidine-lidocaine-magnesium)
Other names:
Precedex
Size
90
Primary endpoint
surgical field using the average category scale (ACS).
During the operation
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2024-05-29
1 organization
3 products
1 indication
Organization
Ain Shams UniversityIndication
Intraoperative Bleeding