Clinical trial NCT04617652: Smooth Extubation With Magnesium Sulphate for General Anesthesia With Endotracheal Intubation
Official title: Efficacy of Magnesium Sulphate on Smoothness of Extubation in Patients Undergoing General Anaesthesia With Endotracheal Intubation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smooth Extubation
Keywords: Magnesium Sulphate
General Anesthesia
Endotracheal Intubation
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

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

Primary outcomes:
measure: smoothness of extubation
timeFrame: Procedure (At time of extubation)
Secondary outcomes:
measure: sedation score
timeFrame: 1 hrs after extubation
measure: sedation score
timeFrame: 1 hour after extubation
measure: heart rate
timeFrame: 5 minutes before induction of anathesia
measure: Mean arterial blood pressure
timeFrame: 5 minutes before induction of anathesia
measure: SpO2
timeFrame: 5 minutes before induction of anathesia
measure: EtCO2
timeFrame: 5 minutes before induction of anathesia
measure: heart rate
timeFrame: 5 minutes after induction of anathesia
measure: Mean arterial blood pressure
timeFrame: 5 minutes after induction of anathesia
measure: SpO2
timeFrame: 5 minutes after induction of anathesia
measure: EtCO2
timeFrame: 5 minutes after induction of anathesia
measure: heart rate
timeFrame: 10 minutes after induction of anathesia
measure: Mean arterial blood pressure
timeFrame: 10 minutes after induction of anathesia
measure: SpO2
timeFrame: 10 minutes after induction of anathesia
measure: EtCO2
timeFrame: 10 minutes after induction of anathesia
measure: heart rate
timeFrame: 15 minutes after induction of anathesia
measure: Mean arterial blood pressure
timeFrame: 15 minutes after induction of anathesia
measure: SpO2
timeFrame: 15 minutes after induction of anathesia
measure: EtCO2
timeFrame: 15 minutes after induction of anathesia
measure: heart rate
timeFrame: 20 minutes after induction of anathesia
measure: Mean arterial blood pressure
timeFrame: 20 minutes after induction of anathesia
measure: SpO2
timeFrame: 20 minutes after induction of anathesia
measure: EtCO2
timeFrame: 20 minutes after induction of anathesia
measure: visual analogue scale (VAS) pain score
timeFrame: 4 hours after extubation
measure: visual analogue scale (VAS) pain score
timeFrame: 6 hours after extubation
measure: The duration of surgery
timeFrame: 5 minutes after extubation
measure: Intraoperative fentanyl needed
timeFrame: 5 minutes after extubation
measure: The cumulative opioids (morphine) consumption
timeFrame: 6 hours after surgery
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University hospital
state: Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt
Study officials:
affiliation: Fayoum University Hospitals
name: Atef S Khalil, MD
role: PRINCIPAL_INVESTIGATOR
References: