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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anesthesia Complication focused on measuring Magnesium sulfate, anesthesia stress response for intubation

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 2, 2023
    Last Updated
    October 14, 2023
    Sponsor
    Assiut University
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    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

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

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