Smooth Extubation With Magnesium Sulphate for General Anesthesia With Endotracheal Intubation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group M Magnesium group |
Drug: Magnesium sulfate
Patients will receive 1 gm of magnesium in 10 ml over 5 minutes then infusion of 1 gm in 50 ml over one hour.
Other Names:
|
| Placebo Comparator: Group C Control group |
Drug: Normal saline
Patients will receive 10 ml of saline, then infusion of 50 ml of normal saline over one hour.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- smoothness of extubation [Procedure (At time of extubation)]
Smoothness of extubation Grade No coughing on endotracheal tube Coughing on the tube Vomiting Laryngospasm
Secondary Outcome Measures
- sedation score [1 hrs after extubation]
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
- sedation score [1 hour after extubation]
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
- heart rate [5 minutes before induction of anathesia]
hemodynamic parameters
- Mean arterial blood pressure [5 minutes before induction of anathesia]
hemodynamic parameters
- SpO2 [5 minutes before induction of anathesia]
hemodynamic parameters
- EtCO2 [5 minutes before induction of anathesia]
hemodynamic parameters
- heart rate [5 minutes after induction of anathesia]
hemodynamic parameters
- Mean arterial blood pressure [5 minutes after induction of anathesia]
hemodynamic parameters
- SpO2 [5 minutes after induction of anathesia]
hemodynamic parameters
- EtCO2 [5 minutes after induction of anathesia]
hemodynamic parameters
- heart rate [10 minutes after induction of anathesia]
hemodynamic parameters
- Mean arterial blood pressure [10 minutes after induction of anathesia]
hemodynamic parameters
- SpO2 [10 minutes after induction of anathesia]
hemodynamic parameters
- EtCO2 [10 minutes after induction of anathesia]
hemodynamic parameters
- heart rate [15 minutes after induction of anathesia]
hemodynamic parameters
- Mean arterial blood pressure [15 minutes after induction of anathesia]
hemodynamic parameters
- SpO2 [15 minutes after induction of anathesia]
hemodynamic parameters
- EtCO2 [15 minutes after induction of anathesia]
hemodynamic parameters
- heart rate [20 minutes after induction of anathesia]
hemodynamic parameters
- Mean arterial blood pressure [20 minutes after induction of anathesia]
hemodynamic parameters
- SpO2 [20 minutes after induction of anathesia]
hemodynamic parameters
- EtCO2 [20 minutes after induction of anathesia]
hemodynamic parameters
- visual analogue scale (VAS) pain score [4 hours after extubation]
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
- visual analogue scale (VAS) pain score [6 hours after extubation]
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
- The duration of surgery [5 minutes after extubation]
time needed to perform surgery
- Intraoperative fentanyl needed [5 minutes after extubation]
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
- The cumulative opioids (morphine) consumption [6 hours after surgery]
The total amount of opioids received post operative
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fayoum University hospital | Fayoum | Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt | Egypt | 63514 |
Sponsors and Collaborators
- Fayoum University Hospital
Investigators
- Principal Investigator: Atef S Khalil, MD, Fayoum University Hospitals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R142