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Low Dose Magnesium Sulphate

Low Dose Magnesium Sulphate in Nasal Surgery

Status
Enrolling by invitation
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06621004
Enrollment
130
Registered
2024-10-01
Start date
2024-08-25
Completion date
2025-01-31
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mean Arterial Pressure

Brief summary

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

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

Interventions

DRUGPatients will receive propranolol 1-2 mg.

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

DRUGPatient 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).

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
mean arterial blood pressureintraoperativemmHg

Secondary

MeasureTime frameDescription
analgesia24 hours postoperativeVisual analogue score

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026