Propofol and Magnesium Sulfate Intravenous Infusion During Endoscopic Sinus Surgery

NCT ID: NCT04078659

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endoscopic Sinus Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Propofol infusion

Patients received intravenous Propofol infusion

Group Type EXPERIMENTAL

Propofol infusion

Intervention Type 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)

Lidocaine

Intervention Type DRUG

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

Fentanyl

Intervention Type DRUG

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

Propofol

Intervention Type DRUG

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

Atracurium

Intervention Type DRUG

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

Mechanical Ventilation

Intervention Type 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

Patients received intravenous Magnesium Sulfate infusion

Group Type EXPERIMENTAL

Magnesium Sulfate infusion

Intervention Type 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

Lidocaine

Intervention Type DRUG

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

Fentanyl

Intervention Type DRUG

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

Propofol

Intervention Type DRUG

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

Atracurium

Intervention Type DRUG

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

Mechanical Ventilation

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DRUG

Magnesium Sulfate infusion

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

Intervention Type DRUG

Lidocaine

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

Intervention Type DRUG

Fentanyl

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Atracurium

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

Intervention Type DRUG

Mechanical Ventilation

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hazem E Moawed

Role: STUDY_DIRECTOR

Assistant Professor of Anesthesia and Surgical Intensive Care

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nabil A Abd El-Mageed

Al Mansurah, DK, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nabil A Abd El-Mageed, MD

Role: CONTACT

00201001538648 ext. 00201121516041

Hazem E Moawed, MD

Role: CONTACT

00201121516041 ext. 00201121516041

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nabil A Abd El-Mageed, MD

Role: primary

00201001538648 ext. 00201001538648

Hazem E Meawad, MD

Role: backup

00201121516041

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MS ∕18.08.247

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.