Fayoum University hospital
Al Fayyum, Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, 63514, Egypt
NCT Number: NCT04617652
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Al Fayyum, Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, 63514, Egypt
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Magnesium Group
Patients will receive 10 ml of saline, then infusion of 50 ml of normal saline over one hour.
Other names: Placebo Group
Time frame: Procedure (At time of extubation)
Smoothness of extubation Grade
Time frame: 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
Time frame: 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
Time frame: 5 minutes before induction of anathesia
hemodynamic parameters
Time frame: 5 minutes before induction of anathesia
hemodynamic parameters
Time frame: 5 minutes before induction of anathesia
hemodynamic parameters
Time frame: 5 minutes before induction of anathesia
hemodynamic parameters
Time frame: 5 minutes after induction of anathesia
hemodynamic parameters
Time frame: 5 minutes after induction of anathesia
hemodynamic parameters
Time frame: 5 minutes after induction of anathesia
hemodynamic parameters
Time frame: 5 minutes after induction of anathesia
hemodynamic parameters
Time frame: 10 minutes after induction of anathesia
hemodynamic parameters
Time frame: 10 minutes after induction of anathesia
hemodynamic parameters
Time frame: 10 minutes after induction of anathesia
hemodynamic parameters
Time frame: 10 minutes after induction of anathesia
hemodynamic parameters
Time frame: 15 minutes after induction of anathesia
hemodynamic parameters
Time frame: 15 minutes after induction of anathesia
hemodynamic parameters
Time frame: 15 minutes after induction of anathesia
hemodynamic parameters
Time frame: 15 minutes after induction of anathesia
hemodynamic parameters
Time frame: 20 minutes after induction of anathesia
hemodynamic parameters
Time frame: 20 minutes after induction of anathesia
hemodynamic parameters
Time frame: 20 minutes after induction of anathesia
hemodynamic parameters
Time frame: 20 minutes after induction of anathesia
hemodynamic parameters
Time frame: 4 hours after extubation
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time frame: 6 hours after extubation
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time frame: 5 minutes after extubation
time needed to perform surgery
Time frame: 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
Time frame: 6 hours after surgery
The total amount of opioids received post operative
Fayoum University Hospital
Other
Efficacy of Magnesium Sulphate on Smoothness of Extubation in Patients Undergoing General Anaesthesia With Endotracheal Intubation: a Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04365686
Smooth Extubation
Al Fayyum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, Egypt
View Trial Details