Low Dose Magnesium Sulphate

NCT06621004 | Enrolling By Invitation Early Phase 1 DMC

• 1 other identifier: FMASU R205/2024
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

Mean Arterial Pressure

Outcome Measures

Primary Outcomes (1)

• mean arterial blood pressure

  mmHg

  intraoperative

Secondary Outcomes (1)

• analgesia

  24 hours postoperative

Study Arms (2)

propranolol

ACTIVE COMPARATOR

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.

propranolol and magnesium sulphate

ACTIVE COMPARATOR

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.; Drug: Patient receives magnesium sulphate

Interventions

Patients will receive propranolol 1-2 mg. DRUG

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

propranolol; propranolol and magnesium sulphate

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).

propranolol and magnesium sulphate

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 69711, Egypt

Location

Study Officials

• Rania M Hussien

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 1, 2024
• Study Start: August 25, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)