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

Intraoperative Bleeding Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427707
• Other study ID #: FMASU R84/2024
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 15, 2024
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Ain Shams University
• Contact: RANIA M Hussien, MD
• Phone: 01000544520
• Email: drrania_maamon[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Intraoperative Bleeding

Intervention

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
• 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.
• 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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical field using the average category scale (ACS).	Degree of surgical field bleeding	During the operation
Secondary	sedation using Ramsy sedation score	Degree of sedation using Ramsy sedation score	First hour postoperative