An interventional study of Nebulization of magnesium sulfate in Sore Throat, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Assiut University · Not applicable, Interventional, and Prevention
This randomized controlled double blinded study will be carried out on 140 patients underwent elective fit laparoscopic cholecystectomy at El-Rajhi Assiut University Hospital.
Inclusion criteria:
Exclusion criteria:
An online randomization program (http://www.randomizer.org) will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner:
A. Preoperative assessment:
All patients will be subjected to the followings:
Routine Laboratory investigations:
B. Intraoperatively:
SBP, DBP, HR, and blood glucose level will be measured at the following intervals: Baseline (before induction), after premedication (sedation), after induction, after ETT intubation, 3 min later, 6 min later.
Full monitoring data (Blood pressure every 3 minutes, ECG, Nanogram, and pulse oximeter) will be collected till 6 minutes then every 5 minutes. Random blood sugar will be tested 5 minutes pre-intubation, 3minutes and 5 minutes after intubation and recorded.
After end of nebulization, sedation with 2 mg midazolam and IV fluids (10 ml/kg) were infused to avoid tachycardia of dehydration and fear of surgery. Then, we proceed on general anesthesia through Propofol titration + fentanyl 100 mcg + Cis-atracurium 0.15 mg/kg. Endotracheal intubation with cuffed tube and mechanical ventilation with mild increase in respiratory rate 14-16/min to overcome CO2 peritoneal insufflation.
All patients will receive intraoperatively, nalbuphine 0.1 mg/kg + ketorolac 60 mg + paracetamol IV 1 g. Dexamethasone 4mg + Ondansetron 4mg will receive to all patients for prophylaxis against postoperative nausea and vomiting.
After 10 minutes of intubation, a second 2ml IV blood sample will be withdrawn for cortisol level. The centrifugation, serum separation, storage and ELIZA analysis will be done as the baseline sample described above.
C. Postoperative:
After end of surgery, cessation of inhalational anesthesia and reversal of muscle relaxation with neostigmine 2.5 mg+ Atropine 1mg is done. Consumption of isoflurane intraoperatively is recorded. Post operative assessment for pain using Visual Analogue Scale (VAS) will be assessed 2 hours after recovery. VAS is presented as a website10 cm straight line ruler reflecting the extremes of "no pain" equals 0 and "worst pain at the other end(at 10cm), while in between the intensity of pain is represented by corresponding facies.
Time for recovery after stop of isoflurane is estimated. Hypertension is considered when the BP values are 20% above baseline values or SBP > 140 mmHg. Hypotension is considered when BP values are lower than 20% of baseline or SBP \< 90 mmHg and will be treated with 10-20 mg ephedrine. Tachycardia will be considered when HR is higher than 20% of baseline or HR > 100 bpm. Bradycardia is considered when HR values are lower than 50 bpm, treated by I.V. atropine 0.02 mg/kg respiratory depression (the SpO2 \< 95% and need O2 supplementation), and postoperative nausea and vomiting (PONV) is treated by ondansetron 0.1 mg/kg IV.
Measurements:
Exclusion Criteria:
Patient refusal.
Patients will receive nebulized magnesium sulfate in 5 ml (250 mg) over 15 min.
Procedure: Nebulization of magnesium sulfate
Patients will receive nebulized normal saline 5ml, 15 minutes preoperatively
patient will be nebulized with 5 mg magnesium sulfate (5 ml) 15 minutes before induction of anesthesia
Difference between preoperative cortisol level and 6minutes after intubation
cortisol level will be measured preoperatively and 6 minutes after intubation then calculation of the difference between them then comparison between both groups
Time frame: 6 minutes after intubation
NRS for sore throat postoperatively
Pain will be assessed by numeric rating scale NRS asking the patient about his degree of pain graded from 0 to 10 in which 0 refers to no pain at all and 10 refers to the worst pain experienced in life
Time frame: 24 hours
4 grade scale
examination of the degree of laryngeal dysfunction due to sore throat into 4 grades: grade 1 refers to no pain, 2 refers to pain during swallowing, 3 =continuous pain and increases with swallowing and 4 refers to severe pain that hinders eating and necessitates urgent treatment.
Time frame: 24 hours postoperatively
Random blood sugar RBS
RBS refers to stress and known to increase with stress
Time frame: 6 minutes after intubation
No study locations are listed for this record.
Plan to share: Yes
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Assiut University