Propofol and Magnesium Sulfate Intravenous Infusion During Endoscopic Sinus Surgery

NCT04078659 | Unknown DMC

• 1 other identifier: MS ∕18.08.247
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic Sinus surgery usually associated by bleeding, despite using of local vasopressor injection, head up position- controlled hypotension is generally used for control of this purpose. Propofol has been reported as a good agent for controlled hypotension by decreasing systemic vascular resistance secondary to arterial and venous vasodilation and a decrease in myocardial contractility with a dose-dependent property. Magnesium Sulfate also has been reported as an agent of hypotensive anaesthesia by inhibition of the release of norepinephrine by blocking N-type calcium channel at the nerve ending beside acting as a vasodilator. The well known pharmacodynamic effects of the intravenous infusion of propofol or Magnesium Sulfate may prove the advantage of this group in controlling intraoperative blood pressure thus reducing surgical field bleeding.

Conditions

Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (1)

• Mean arterial blood pressure (MAP)

  automatically non invasive measured every 3 minutes , recorded every 15 minutes till the end and 15 minutes after extubation the end and 15 minutes after extubation

  15 minutes after the induction of the hypotensive agent

Secondary Outcomes (9)

• The blood loss

  at the end of the surgery

• The number of patients will need nitroglycerine and dose

  at the end of the surgery

• Use of Ephedrine

  at the end of the surgery

• Need for blood transfusion

  at the end of the surgery

• Postoperative Ramsey sedation

  for the first hour postoperative

Study Arms (2)

Propofol infusion

EXPERIMENTAL

Patients received intravenous Propofol infusion

Drug: Propofol infusion; Drug: Lidocaine; Drug: Fentanyl; Drug: Propofol; Drug: Atracurium; Procedure: Mechanical Ventilation

Magnesium Sulfate infusion

EXPERIMENTAL

Patients received intravenous Magnesium Sulfate infusion

Drug: Magnesium Sulfate infusion; Drug: Lidocaine; Drug: Fentanyl; Drug: Propofol; Drug: Atracurium; Procedure: Mechanical Ventilation

Interventions

Propofol infusion DRUG

Following induction of anaesthesia, propofol infusion will be started 75 mcg/kg/min for the first 10-15 minutes, then a maintenance infusion of propofol (50 mcg/kg /min)

Propofol infusion

Magnesium Sulfate infusion DRUG

Before induction of anaesthesia, Magnesium Sulfate infusion will be started at 40 mg/kg in 100 ml saline over 10 minutes as the loading dose then Magnesium sulfate infusion 10-15 mg/kg/hr started immediately after induction of anaesthesia

Magnesium Sulfate infusion

Lidocaine DRUG

Patients will receive iv lidocaine 1.5 mg/kg before induction of anaesthesia

Magnesium Sulfate infusion; Propofol infusion

Fentanyl DRUG

Patients will receive fentanyl 1-2 mcg/kg before induction of anaesthesia

Magnesium Sulfate infusion; Propofol infusion

Propofol DRUG

Patients will receive propofol in a dose of 1-2 mg /kg

Magnesium Sulfate infusion; Propofol infusion

Atracurium DRUG

Patients will receive 0.6 mg /kg iv atracurium over 60 sec, to facilitate tracheal intubation

Magnesium Sulfate infusion; Propofol infusion

Mechanical Ventilation PROCEDURE

Patients lungs will be ventilated using the volume controlled mechanically ventilated with 40% oxygen in the air with positive end-expiratory pressure (PEEP) of 5 cmH2O, tidal volume 500 ml and Respiratory Rate of 12 per minute

Magnesium Sulfate infusion; Propofol infusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists Physical Classes I or II

You may not qualify if:

• Patients refusal
• Patients with hypersensitivity for any drug used in the study including magnesium, propofol or isoflurane
• Patients receiving magnesium sulfate supplementation
• Patients receiving drugs known to have significant interaction.
• Patients with ischemic heart disease
• Patients with heart defects
• Patients with significant heart failure
• Patients with increased intracranial pressure.
• Patients with systemic hypertension

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Nabil A Abd El-Mageed

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Lidocaine; Fentanyl; Propofol; Atracurium; Respiration, Artificial

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzylisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Hazem E Moawed

  Assistant Professor of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

Central Study Contacts

Nabil A Abd El-Mageed, MD

CONTACT

00201001538648; nabil-abdelraouf@yahoo.com

Hazem E Moawed, MD

CONTACT

00201121516041; hazemmoawad@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: September 6, 2019
• Study Start: September 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)