Magnesium Sulfate in Surgical Stress Attenuation Postoperative Sore Throat and Stress Response Induced Tracheal Intubation

Anesthesia Intubation Complication Clinical Trial

— Magnesium  

Official title:

Effect of Magnesium Sulfate Nebulization on Postoperative Sore Throat and Stress Response Induced Tracheal Intubation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06091631
• Other study ID #: Attenuation of surgical stress
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Magnesium sulfate has many mechanisms of action for attenuating the stress response as inhibition of catecholamine releasing from the adrenal medulla, keeping the plasma concentration of epinephrine at a fixed level, decreasing the circulating norepinephrine level when compared to that of a control group[ and also has a vasodilation effect on systemic and coronary blood vessels by blocking calcium ion in vascular smooth muscle.-Methyl- D-Aspartate (NMDA) antagonism is an amazing recent discovery for magnesium sulphate to play an important role in stress response.

In this study, we will study the effects of nebulized magnesium sulfate on hemodynamics during intubation.

Description:

Inclusion criteria

• 20-50 years old

• ASA: 1, 2

• Elective fit laparoscopic cholecystectomy Exclusion criteria

• Patient refusal

• patients with history of hypersensitivity to magnesium sulphate

• patients with coronary ischemic disease, atrioventricular block of any degree, known cardiac arrhythmias, heart failure

• on beta blockers or calcium channel blockers

• expected difficult intubation (Mallampati 4)

• Body mass index > 40

Study tools:

Following institutional ethical committee approval and written informed consent,a prospective randomized double-blinded study. After written informed consent wil be given, 100 patients, ASA 1 or 2, aged between 20 - 50 years, scheduled for elective surgery with Orotracheal Intubation (OTI) will be assessed for eligibility. Patients will be recruited in the study divided into two equal groups; Patients in Group A: will receive nebulized magnesium sulfate in 3 ml (240 mg) over 15 min, While group B: will receive nebulized normal saline in 3 ml over 15 min, ending 5 min before the induction of anesthesia. 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) wil 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.

After end of nebulization, sedation with 2 mg midazolam and IV fluids (10 ml/kg) will be infused to avoid tachycardia of dehydration and fear of surgery. Then, we proceed on general anesthesia through propool titration + fentanyl 100 mcg + Cisatracurium 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 be received to all patients for prophylaxis against postoperative nausea and vomiting. After end of surgery, cessation of inhalational anesthesia and reversal of muscle relaxation with neostigmine 2.5 mg+ Atropine 1mg will be done.

Consumption of isoflurane intraoperatively will be recorded. Post operative assessment for pain using VAS score will be assessed 2 hours after recovery.

Time for recovery after stop of isoflurane will be estimated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• 20-50 years old

• ASA: 1, 2

• Elective fit laparoscopic cholecystectomy

Exclusion Criteria:

• -Patient refusal

• patients with history of hypersensitivity to magnesium sulphate

• patients with coronary ischemic disease, atrioventricular block of any degree, known cardiac arrhythmias, heart failure

• on beta blockers or calcium channel blockers

• expected difficult intubation (Mallampati 4)

• Body mass index > 40

Related Conditions & MeSH terms

• Anesthesia Complication
• Anesthesia Intubation Complication
• Pharyngitis

Intervention

Procedure:
• Magnesium sulfate vaporization
pre-opeative magnesium sulfate vaporization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-operative sore throat at 0 hours in both groups	Incidence of post-operative sore throat 0 h	at 0 hours in both groups
Primary	Incidence of post-operative sore throat at 2 hours in both groups	Incidence of post-operative sore throat 2 h	at 2 hours in both groups
Primary	Incidence of post-operative sore throat at 4 hours in both groups	Incidence of post-operative sore throat 4 h	at 4 hours in both groups
Primary	Incidence of post-operative sore throat at 24 hours in both groups	Incidence of post-operative sore throat 24 h	at 24 hours in both groups
Secondary	Improvement in postoperative stress response after (3, 6) minutes including: • Heart rate > 20% baseline • Systolic and mean BP >25% baseline • Random blood sugar increase > 50 mg/dl from baseline	Improvement in postoperative stress response after (3, 6) minutes including: Heart rate > 20% baseline; Systolic and mean BP >25% baseline; Random blood sugar increase > 50 mg/dl from baseline	(3, 6) minutes
Secondary	Effect on Pain score VAS 2hours after recovery	Effect on Pain score VAS visual analogue scale.	2hours after recovery