Low Dose Magnesium Sulphate

NCT ID: NCT06621004

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-25
• Study Completion Date: 2025-01-31

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

Conditions

Mean Arterial Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Patients will receive propranolol 1-2 mg.

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Patients will receive propranolol 1-2 mg.

Intervention Type: DRUG

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

Patient receives magnesium sulphate

Intervention Type: 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).

Interventions

Patients will receive propranolol 1-2 mg.

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

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Rania Maher Hussien, MD

Assistant professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rania M Hussien

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU R205/2024

Identifier Type: -

Identifier Source: org_study_id