Clinical trial NCT06621004: Low Dose Magnesium Sulphate
Official title: Low Dose Magnesium Sulphate in Nasal Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Mean Arterial Pressure
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: mean arterial blood pressure
timeFrame: intraoperative
Secondary outcomes:
measure: analgesia
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Rania M Hussien
role: PRINCIPAL_INVESTIGATOR
References: