Low Dose Magnesium Sulphate

Early Phase 1

• Conditions: Mean Arterial Pressure
• Interventions: Drug: Patients will receive propranolol 1-2 mg.; Drug: Patient receives magnesium sulphate

• Registration Number: NCT06621004
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study Start: 2024-08-25
• Study First Submitted: 2024-09-29
• Study First Submitted QC: 2024-09-29
• Status Verified: 2024-10
• Study First Posted: 2024-10-01
• Last Update Submitted: 2024-10-05
• Last Update Posted: 2024-10-09
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propranolol	Patients will receive propranolol 1-2 mg.	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.
propranolol and magnesium sulphate	Patients will receive propranolol 1-2 mg.	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.
propranolol and magnesium sulphate	Patient receives 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.

Primary Outcome Measures

Name	Time	Method
mean arterial blood pressure	intraoperative	mmHg

Secondary Outcome Measures

Name	Time	Method
analgesia	24 hours postoperative	Visual analogue score

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt