Magnesium Sulfate in Surgical Stress Attenuation Postoperative Sore Throat and Stress Response Induced Tracheal Intubation (Magnesium)
Primary Purpose
Anesthesia Complication, Anesthesia Intubation Complication
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnesium sulfate vaporization
Sponsored by
About this trial
This is an interventional other trial for Anesthesia Complication focused on measuring Magnesium sulfate, anesthesia stress response for intubation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Magnesium sulfate
Control
Arm Description
will receive magnesium sulfate inhation
Will receive distilled water vaporization
Outcomes
Primary Outcome Measures
Incidence of post-operative sore throat at 0 hours in both groups
Incidence of post-operative sore throat 0 h
Incidence of post-operative sore throat at 2 hours in both groups
Incidence of post-operative sore throat 2 h
Incidence of post-operative sore throat at 4 hours in both groups
Incidence of post-operative sore throat 4 h
Incidence of post-operative sore throat at 24 hours in both groups
Incidence of post-operative sore throat 24 h
Secondary Outcome Measures
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
Effect on Pain score VAS 2hours after recovery
Effect on Pain score VAS visual analogue scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06091631
Brief Title
Magnesium Sulfate in Surgical Stress Attenuation Postoperative Sore Throat and Stress Response Induced Tracheal Intubation
Acronym
Magnesium
Official Title
Effect of Magnesium Sulfate Nebulization on Postoperative Sore Throat and Stress Response Induced Tracheal Intubation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Complication, Anesthesia Intubation Complication
Keywords
Magnesium sulfate, anesthesia stress response for intubation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups are investigated. Each group consists of 50 patients. First group will receive magnesium sulfate inhalation . The other group will receive distilled water inhation
Masking
Participant
Masking Description
the participant will not know whither a magnesium sulfate inhalation or distilled water in the vaporizer
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnesium sulfate
Arm Type
Experimental
Arm Description
will receive magnesium sulfate inhation
Arm Title
Control
Arm Type
No Intervention
Arm Description
Will receive distilled water vaporization
Intervention Type
Procedure
Intervention Name(s)
Magnesium sulfate vaporization
Intervention Description
pre-opeative magnesium sulfate vaporization
Primary Outcome Measure Information:
Title
Incidence of post-operative sore throat at 0 hours in both groups
Description
Incidence of post-operative sore throat 0 h
Time Frame
at 0 hours in both groups
Title
Incidence of post-operative sore throat at 2 hours in both groups
Description
Incidence of post-operative sore throat 2 h
Time Frame
at 2 hours in both groups
Title
Incidence of post-operative sore throat at 4 hours in both groups
Description
Incidence of post-operative sore throat 4 h
Time Frame
at 4 hours in both groups
Title
Incidence of post-operative sore throat at 24 hours in both groups
Description
Incidence of post-operative sore throat 24 h
Time Frame
at 24 hours in both groups
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
(3, 6) minutes
Title
Effect on Pain score VAS 2hours after recovery
Description
Effect on Pain score VAS visual analogue scale.
Time Frame
2hours after recovery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Magnesium Sulfate in Surgical Stress Attenuation Postoperative Sore Throat and Stress Response Induced Tracheal Intubation
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