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Completed

NCT Number: NCT04617652

Smooth Extubation With Magnesium Sulphate for General Anesthesia With Endotracheal Intubation

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fayoum University hospital

Al Fayyum, Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, 63514, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

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

normal saline

Drug

Patients will receive 10 ml of saline, then infusion of 50 ml of normal saline over one hour.

Other names: Placebo Group

Primary outcomes

  1. smoothness of extubation

    Time frame: Procedure (At time of extubation)

    Smoothness of extubation Grade

    • No coughing on endotracheal tube
    • Coughing on the tube
    • Vomiting
    • Laryngospasm

Secondary outcomes

  1. sedation score

    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

  2. sedation score

    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

  3. heart rate

    Time frame: 5 minutes before induction of anathesia

    hemodynamic parameters

  4. Mean arterial blood pressure

    Time frame: 5 minutes before induction of anathesia

    hemodynamic parameters

  5. SpO2

    Time frame: 5 minutes before induction of anathesia

    hemodynamic parameters

  6. EtCO2

    Time frame: 5 minutes before induction of anathesia

    hemodynamic parameters

  7. heart rate

    Time frame: 5 minutes after induction of anathesia

    hemodynamic parameters

  8. Mean arterial blood pressure

    Time frame: 5 minutes after induction of anathesia

    hemodynamic parameters

  9. SpO2

    Time frame: 5 minutes after induction of anathesia

    hemodynamic parameters

  10. EtCO2

    Time frame: 5 minutes after induction of anathesia

    hemodynamic parameters

  11. heart rate

    Time frame: 10 minutes after induction of anathesia

    hemodynamic parameters

  12. Mean arterial blood pressure

    Time frame: 10 minutes after induction of anathesia

    hemodynamic parameters

  13. SpO2

    Time frame: 10 minutes after induction of anathesia

    hemodynamic parameters

  14. EtCO2

    Time frame: 10 minutes after induction of anathesia

    hemodynamic parameters

  15. heart rate

    Time frame: 15 minutes after induction of anathesia

    hemodynamic parameters

  16. Mean arterial blood pressure

    Time frame: 15 minutes after induction of anathesia

    hemodynamic parameters

  17. SpO2

    Time frame: 15 minutes after induction of anathesia

    hemodynamic parameters

  18. EtCO2

    Time frame: 15 minutes after induction of anathesia

    hemodynamic parameters

  19. heart rate

    Time frame: 20 minutes after induction of anathesia

    hemodynamic parameters

  20. Mean arterial blood pressure

    Time frame: 20 minutes after induction of anathesia

    hemodynamic parameters

  21. SpO2

    Time frame: 20 minutes after induction of anathesia

    hemodynamic parameters

  22. EtCO2

    Time frame: 20 minutes after induction of anathesia

    hemodynamic parameters

  23. visual analogue scale (VAS) pain score

    Time frame: 4 hours after extubation

    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  24. visual analogue scale (VAS) pain score

    Time frame: 6 hours after extubation

    the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain

  25. The duration of surgery

    Time frame: 5 minutes after extubation

    time needed to perform surgery

  26. Intraoperative fentanyl needed

    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

  27. The cumulative opioids (morphine) consumption

    Time frame: 6 hours after surgery

    The total amount of opioids received post operative

Sponsors and collaborators

Lead sponsor

Fayoum University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2020
Registry last updated
Aug 19, 2021

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.

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