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

Phase 2

Recruiting

• Conditions: Intraoperative Bleeding
• Interventions: Drug: Intravenous Infusion of propofol, lidocaine, Magnesium sulfate; Drug: Intravenous infusion of ketamine, lidocaine, Magnesium sulfate; Drug: Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate

• Registration Number: NCT06427707
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-24
• Study Start: 2024-06-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-05
• Last Update Posted: 2024-10-09
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group PLM (propofol-lidocaine-magnesium)	Intravenous Infusion of propofol, lidocaine, Magnesium sulfate	intravenous infusion of propofol, lidocaine and magnesium sulfate.
Group KLM (ketamine-lidocaine-magnesium)	Intravenous infusion of ketamine, lidocaine, Magnesium sulfate	intravenous infusion of Ketamine, lidocaine and magnesium sulfate
Group DLM (Dexmeditomidine-lidocaine-magnesium)	Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate	Intravenous infusion of Dexmeditomidine, lidocaine and magnesium sulfate

Primary Outcome Measures

Name	Time	Method
surgical field using the average category scale (ACS).	During the operation	Degree of surgical field bleeding

Secondary Outcome Measures

Name	Time	Method
sedation using Ramsy sedation score	First hour postoperative	Degree of sedation using Ramsy sedation score

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt