Propofol and Magnesium Sulfate Intravenous Infusion During Endoscopic Sinus Surgery

September 2, 2019 updated by: Mansoura University

Controlled Hypotension During Endoscopic Sinus Surgery: A Comparison of Propofol and Magnesium Sulfate

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.

Study Overview

Detailed Description

The aim of the work to compare the efficacy of propofol and magnesium sulfate to control blood pressure during endoscopic sinus surgery and the resultant effects on the quality of the surgical field including bleeding and visibility.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • DK
      • Mansoura, DK, Egypt, 050
        • Nabil A Abd El-Mageed
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Maha A Abo-Zeid, MD
        • Sub-Investigator:
          • Mohamed E Mohamed, M.Sec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists Physical Classes I or II

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol infusion
Patients received intravenous Propofol infusion
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)
Patients will receive iv lidocaine 1.5 mg/kg before induction of anaesthesia
Patients will receive fentanyl 1-2 mcg/kg before induction of anaesthesia
Patients will receive propofol in a dose of 1-2 mg /kg
Patients will receive 0.6 mg /kg iv atracurium over 60 sec, to facilitate tracheal intubation
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
Experimental: Magnesium Sulfate infusion
Patients received intravenous Magnesium Sulfate infusion
Patients will receive iv lidocaine 1.5 mg/kg before induction of anaesthesia
Patients will receive fentanyl 1-2 mcg/kg before induction of anaesthesia
Patients will receive propofol in a dose of 1-2 mg /kg
Patients will receive 0.6 mg /kg iv atracurium over 60 sec, to facilitate tracheal intubation
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial blood pressure (MAP)
Time Frame: 15 minutes after the induction of the hypotensive agent
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The blood loss
Time Frame: at the end of the surgery
The blood loss would be calculated using the following formula Blood Loss = Blood Volume. In )Hct 1 / Hct2)
at the end of the surgery
The number of patients will need nitroglycerine and dose
Time Frame: at the end of the surgery
The number of patients will need nitroglycerine
at the end of the surgery
Use of Ephedrine
Time Frame: at the end of the surgery
The number of patients will need ephedrine
at the end of the surgery
Need for blood transfusion
Time Frame: at the end of the surgery
The number of patient need for blood transfusion
at the end of the surgery
Postoperative Ramsey sedation
Time Frame: for the first hour postoperative
patient awake, anxious, agitated or restless 2 patient awake -1co operative, oriented and tranquil 3 patient drowsy with respond to command 4 patient asleep brisk response to glabella tap or loud auditory sound 5 patient asleep with sluggish response to stimulus 6 patient hasno response to nail bed pressure or othernoxious stimuli
for the first hour postoperative
Simplified post operative nausea and vomiting score
Time Frame: for the first 24 hour postoperative
using impact scale score evaluation
for the first 24 hour postoperative
Recovery time
Time Frame: one hour after extubation
time needed to reach modified aldrete score> or=9)
one hour after extubation
Heart rate (HR)
Time Frame: 15 minutes after the start of the hypotensive agent
15 minutes after the start of the hypotensive agent
surgical field assessment
Time Frame: 2 hours intraoperative
By the surgeon interms of bleeding and visibility using a 6-option Liker-scale scale adapted from Fromme el al. (26): 0 = no bleeding; 1 = minor bleeding, but no aspiration required; 2 = minor bleeding, aspiration required; 3 = minor bleeding, frequent aspiration required; 4 = moderate bleeding, visible� only with aspiration; 5 = severe bleeding, continuous aspiration required
2 hours intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Hazem E Moawed, assistant professor of Anesthesia and Surgical Intensive Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

September 2, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 2, 2019

Last Verified

September 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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