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Enrolling by Invitation

NCT Number: NCT06621004

Low Dose Magnesium Sulphate

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

Enrolling by Invitation

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ain Shams University

Cairo, 69711, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patients will receive propranolol 1-2 mg.

Drug

Patients will receive propranolol 1-2 mg. prepared in a 10 ml syringe (100 ug/ml).

Patient receives magnesium sulphate

Drug

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).

Primary outcomes

  1. mean arterial blood pressure

    Time frame: intraoperative

    mmHg

Secondary outcomes

  1. analgesia

    Time frame: 24 hours postoperative

    Visual analogue score

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Low Dose Magnesium Sulphate in Nasal Surgery

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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