Low Dose Magnesium Sulphate (MgSo3)

October 5, 2024 updated by: Rania Maher Hussien, MD, Ain Shams University

Low Dose Magnesium Sulphate in Nasal Surgery

This clinical trial aims to compare Patients who receive propranolol 1-2 mg to Patients who receive propranolol 1-2 mg in addition to magnesium sulphate infusion 10 mg/kg to see if IV magnesium can stability mean arterial blood pressure and heart rate in patients undergoing nasal surgeries as well as the quality of postoperative analgesia, degree of sedation mean arterial blood pressure and HR will be recorded intraoperative and Participants will be asked to rate the pain at the first, second, fourth, sixth and 24th postoperative hour using the VAS score.

  • Analgesic requirements: The time to first demand analgesia and the total amount of analgesia required in the 1st 24 will be recorded.
  • Sedation score: the degree of sedation will be assessed using the Ramsy sedation score

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This prospective, randomized controlled clinical trial aims to establish the effect of magnesium sulphate during nasal surgery regarding deliberate hypotension, postoperative analgesia and sedation with minimal side effects.

this study will be conducted in the plastic surgery and ENT operating rooms at ASUH 130 patients undergoing rhinoplasty or functional endoscopic sinus surgery (FESS) operation under general anaesthesia.

patients will be allocated into 2 groups 65 patients each using a computer-generated randomization list.

Group (P): Patients will receive propranolol 1-2 mg. Group (PM): Patients will receive propranolol 1-2 mg in addition to magnesium sulphate infusion 10 mg/kg.

  • ABP and HR are continuously monitored and will be recorded before the start of anaesthesia (T1), after intubation (T2), at skin incision (T3), at manipulation of nasal bones (T4), at extubation (T5), before discharge to PACU (T6), and after 30 min in PACU.
  • Surgical duration (time from skin incision till skin closure).
  • Extubation time (from the end of anaesthesia to extubation)
  • Modified Alderete score will be assessed and recorded every 5 minutes until discharge. Patients will be discharged upon achieving an Aldrete score of ≥ 9.
  • The time to discharge will be recorded.
  • VAS score for pain:
  • Analgesic requirements: The time to first demand analgesia and the total amount of analgesia required in the 1st 24 will be recorded.
  • Sedation score: the degree of sedation will be assessed using the Ramsy sedation score where all be recorded

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Early Phase 1

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt, 69711
        • Ain shams university

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing rhinoplasty or functional endoscopic sinus surgery (FESS) operation under general anesthesia
  • ASA I or II
  • Duration of surgery will be 1-2 hours

Exclusion Criteria:

  • Hypertension,
  • Myasthenia gravis or other muscular disease,
  • Impaired kidney or liver functions,
  • History of drug or alcohol abuse,
  • History of antidepressant and calcium channel blocker use,
  • Mental retardation and hysterical patients.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: propranolol
1 mg propranolol will be prepared in a 10 ml syringe (100 ug/ml). Propranolol will be given 200-300 ug bolus followed by increments of 100 ug until MABP becomes 50-60 mmHg and HR 50 - 70 b/ m.
Drug: Patients will receive propranolol 1-2 mg.
Patients will receive propranolol 1-2 mg. prepared in a 10 ml syringe (100 ug/ml).
Active Comparator: propranolol and magnesium sulphate
1g MgSo3 ampoule (10ml) will be prepared in a syringe pump to be given at a rate of 40 ml/hr in the group and 1 mg propranolol will be prepared in a 10 ml syringe (100 ug/ml). Propranolol will be given 200-300 ug bolus followed by increments of 100 ug until MABP becomes 50-60 mmHg and HR 50 - 70 b/ m.
Drug: Patients will receive propranolol 1-2 mg.
Patients will receive propranolol 1-2 mg. prepared in a 10 ml syringe (100 ug/ml).
Drug: Patient receives magnesium sulphate
Magnesium sulphate 10%: 1g ampoule (10ml), will be prepared in a syringe pump to be given at a rate of 40 ml/hr . Another syringe of 10 ml 0.9% sodium chloride will be prepared to be given in group (P).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean arterial blood pressure
Time Frame: intraoperative
mmHg
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesia
Time Frame: 24 hours postoperative
Visual analogue score
24 hours postoperative

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Rania M Hussien, Ain shams university

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 (Actual)

August 25, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

September 29, 2024

First Submitted That Met QC Criteria

September 29, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 5, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R205/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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