Smooth Extubation With Magnesium Sulphate for General Anesthesia With Endotracheal Intubation

Study Overview
=================
Brief Summary
-----------------
Tracheal extubation is a critical event in the anaesthetic management of patients undergoing general anaesthesia with endotracheal intubation for elective procedures. It the state of art to provide suitable conditions for smooth extubation and avoid coughing, bucking, straining and/or laryngospasm. Several methods have been described to provide a smooth extubation, including the use of remifentanil infusion, dexmedetomidine or fentanyl. Because of its anti-inflammatory and analgesic effects and lack of respiratory depressant actions, magnesium sulphate could be an attractive alternative.

Detailed Description
-----------------
A written informed consent will be obtained from all the patients. On arrival to the preparation room intravenous cannula will be inserted, no sedation will be given. In the operating theater standard monitors, non-invasive blood pressure, oxygen saturation and electrocardiogram will be applied before induction of anesthesia, capnography after induction of anesthesia and baseline heart rate (HR), mean arterial blood pressure (MAP) and oxygen saturation (SpO2 ) will be recorded. All patients in both groups will receive standardized anesthetic technique in the form of intravenous (i.v.) propofol 2 mg/kg, i.v. fentanyl 1-2 lg/kg and atracurium 0.5 mg/kg to facilitate endo-tracheal intubation, mechanical ventilation will be adjusted to keep end tidal carbon dioxide (EtCO2) between 30 and 35 mmHg, and all drugs will be based on ideal body weight. Isoﬂurane 1% in 50% oxygen and air, and 0.15 mg/kg atracurium every 20 min will be given for maintenance of anesthesia. Intraoperative HR, MAP, EtCO2 and SpO2 values will be recorded at 5- minute intervals till the end of operation. HR and MAP will be maintained within ±20% of the baseline values. Hypotension (deﬁned as MAP < 20% of the baseline value) will be treated by a bolus of 200 ml Ringer's solution if not responding increments of 3-9 mg ephedrine will be given. Hypertension (deﬁned as MAP > 20% of the baseline value) and/or tachycardia (deﬁned as HR > 20% of the baseline value) a supplemental dose (25-50 µg) fentanyl will be given or increasing concentration of isoﬂurane. Bradycardia (HR < 50 beat per minute) persisting for >2 min will be treated with atropine, 0.4 mg i.v. boluses. Intra-operatively i.v. ondansetron, 4 mg (Zofran, GlaxoSmithKline) will be given for prevention of postoperative nausea and vomiting. After induction of anaesthesia patients will be divided into 2 groups: group C (control group) n= 30 patients will receive 10 ml of saline, then infusion of 50 ml of normal saline over one hour. Group M (magnesium group n=30 patients) will receive 1 gm of magnesium in 10 ml over 5 minutes then infusion of 1 gm in 50 ml over one hour. By the end of surgery isoﬂurane will be discontinued and the residual neuromuscular block will be antagonized with neostigmine 0.05 mg/kg, given with atropine 0.02 mg/kg, the endotracheal tube will be removed after return of spontaneous breathing, and the patient will obey commands in semi-sitting position, then the patient will be transferred to the post-anesthesia care unit (PACU)

Official Title
-----------------
Efficacy of Magnesium Sulphate on Smoothness of Extubation in Patients Undergoing General Anaesthesia With Endotracheal Intubation: a Randomized Controlled Trial

Conditions
-----------------
Smooth Extubation

Intervention / Treatment
-----------------
* Drug: Magnesium sulfate
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgeries that need endotracheal intubation. Duration of surgery 1-3 hours ASA Ⅰ-Ⅱ Exclusion Criteria: Refusal of patients. Patients with hypersensitivity to the study drug. Patients with cardiac disorders, bundle branch block, hart block Neuromuscular disease, calcium channel blocker medication or hypermagnesemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group M<br>Magnesium group | Drug: Magnesium sulfate<br>* Patients will receive 1 gm of magnesium in 10 ml over 5 minutes then infusion of 1 gm in 50 ml over one hour.<br>* Other names: Magnesium Group;|
| Placebo Comparator: Group C<br>Control group | Drug: Normal saline<br>* Patients will receive 10 ml of saline, then infusion of 50 ml of normal saline over one hour.<br>* Other names: Placebo Group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoothness of extubation | Smoothness of extubation Grade No coughing on endotracheal tube Coughing on the tube Vomiting Laryngospasm | Procedure (At time of extubation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation score | Ramsey sedation score (RSS): 1 - Anxious, agitated or restless; 2 - Cooperative and oriented; 3 - Responsive to commands; 4 - Asleep, but response to light glabellar tap or loud auditory; 5 - Asleep, sluggish response to glabellar tab or auditory response; and 6 - Asleep, no response | 1 hrs after extubation | 
| sedation score | Ramsey sedation score (RSS): 1 - Anxious, agitated or restless; 2 - Cooperative and oriented; 3 - Responsive to commands; 4 - Asleep, but response to light glabellar tap or loud auditory; 5 - Asleep, sluggish response to glabellar tab or auditory response; and 6 - Asleep, no response | 1 hour after extubation | 
| heart rate | hemodynamic parameters | 5 minutes before induction of anathesia | 
| Mean arterial blood pressure | hemodynamic parameters | 5 minutes before induction of anathesia | 
| SpO2 | hemodynamic parameters | 5 minutes before induction of anathesia | 
| EtCO2 | hemodynamic parameters | 5 minutes before induction of anathesia | 
| heart rate | hemodynamic parameters | 5 minutes after induction of anathesia | 
| Mean arterial blood pressure | hemodynamic parameters | 5 minutes after induction of anathesia | 
| SpO2 | hemodynamic parameters | 5 minutes after induction of anathesia | 
| EtCO2 | hemodynamic parameters | 5 minutes after induction of anathesia | 
| heart rate | hemodynamic parameters | 10 minutes after induction of anathesia | 
| Mean arterial blood pressure | hemodynamic parameters | 10 minutes after induction of anathesia | 
| SpO2 | hemodynamic parameters | 10 minutes after induction of anathesia | 
| EtCO2 | hemodynamic parameters | 10 minutes after induction of anathesia | 
| heart rate | hemodynamic parameters | 15 minutes after induction of anathesia | 
| Mean arterial blood pressure | hemodynamic parameters | 15 minutes after induction of anathesia | 
| SpO2 | hemodynamic parameters | 15 minutes after induction of anathesia | 
| EtCO2 | hemodynamic parameters | 15 minutes after induction of anathesia | 
| heart rate | hemodynamic parameters | 20 minutes after induction of anathesia | 
| Mean arterial blood pressure | hemodynamic parameters | 20 minutes after induction of anathesia | 
| SpO2 | hemodynamic parameters | 20 minutes after induction of anathesia | 
| EtCO2 | hemodynamic parameters | 20 minutes after induction of anathesia | 
| visual analogue scale (VAS) pain score | the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain | 4 hours after extubation | 
| visual analogue scale (VAS) pain score | the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain | 6 hours after extubation | 
| The duration of surgery | time needed to perform surgery | 5 minutes after extubation | 
| Intraoperative fentanyl needed | The amount of Fentanyl given intraoperative as fentanyl will be given when either heart rate or NIBP(Non-Invasive Blood Pressure) report an increase by more than 20% of the basal records | 5 minutes after extubation | 
| The cumulative opioids (morphine) consumption | The total amount of opioids received post operative | 6 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnesium Sulphate, General Anesthesia, Endotracheal Intubation