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Smooth ExtubationPhase 4NCT04617652

Smooth Extubation With Magnesium Sulphate for General Anesthesia With Endotracheal Intubation

A Phase 4 study testing Magnesium sulfate and Normal saline in people with Smooth Extubation, run by Fayoum University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Smooth Extubation
What is being tested?
Magnesium sulfate and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Aug 2020to 1 Apr 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Elective surgeries that need endotracheal intubation.
  • Duration of surgery 1-3 hours
  • ASA Ⅰ-Ⅱ

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum University hospital

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

Other trials in Egypt

About this study

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

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.

Read the 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)

Being tested
Magnesium sulfate, Normal saline
Keywords
Magnesium Sulphate, General Anesthesia, Endotracheal Intubation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium sulfateDrug

    Also called Magnesium Group

    Patients will receive 1 gm of magnesium in 10 ml over 5 minutes then infusion of 1 gm in 50 ml over one hour.

  • Normal salineDrug

    Also called Placebo Group

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

Study groups in NCT04617652
Study groupRoleWhat they receive
Group MActive comparatorMagnesium group
Receives: Drug: Magnesium sulfate
Group CPlacebo comparatorControl group
Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. smoothness of extubation

    Smoothness of extubation Grade

    1. No coughing on endotracheal tube
    2. Coughing on the tube
    3. Vomiting
    4. Laryngospasm

    Measured: Procedure (At time of extubation)

Secondary outcomes (27)
  1. 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

    Measured: 1 hrs after extubation

  2. 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

    Measured: 1 hour after extubation

  3. heart rate

    hemodynamic parameters

    Measured: 5 minutes before induction of anathesia

  4. Mean arterial blood pressure

    hemodynamic parameters

    Measured: 5 minutes before induction of anathesia

  5. SpO2

    hemodynamic parameters

    Measured: 5 minutes before induction of anathesia

  6. EtCO2

    hemodynamic parameters

    Measured: 5 minutes before induction of anathesia

  7. heart rate

    hemodynamic parameters

    Measured: 5 minutes after induction of anathesia

  8. Mean arterial blood pressure

    hemodynamic parameters

    Measured: 5 minutes after induction of anathesia

  9. SpO2

    hemodynamic parameters

    Measured: 5 minutes after induction of anathesia

  10. EtCO2

    hemodynamic parameters

    Measured: 5 minutes after induction of anathesia

  11. heart rate

    hemodynamic parameters

    Measured: 10 minutes after induction of anathesia

  12. Mean arterial blood pressure

    hemodynamic parameters

    Measured: 10 minutes after induction of anathesia

  13. SpO2

    hemodynamic parameters

    Measured: 10 minutes after induction of anathesia

  14. EtCO2

    hemodynamic parameters

    Measured: 10 minutes after induction of anathesia

  15. heart rate

    hemodynamic parameters

    Measured: 15 minutes after induction of anathesia

  16. Mean arterial blood pressure

    hemodynamic parameters

    Measured: 15 minutes after induction of anathesia

  17. SpO2

    hemodynamic parameters

    Measured: 15 minutes after induction of anathesia

  18. EtCO2

    hemodynamic parameters

    Measured: 15 minutes after induction of anathesia

  19. heart rate

    hemodynamic parameters

    Measured: 20 minutes after induction of anathesia

  20. Mean arterial blood pressure

    hemodynamic parameters

    Measured: 20 minutes after induction of anathesia

  21. SpO2

    hemodynamic parameters

    Measured: 20 minutes after induction of anathesia

  22. EtCO2

    hemodynamic parameters

    Measured: 20 minutes after induction of anathesia

  23. visual analogue scale (VAS) pain score

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

    Measured: 4 hours after extubation

  24. visual analogue scale (VAS) pain score

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

    Measured: 6 hours after extubation

  25. The duration of surgery

    time needed to perform surgery

    Measured: 5 minutes after extubation

  26. 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

    Measured: 5 minutes after extubation

  27. The cumulative opioids (morphine) consumption

    The total amount of opioids received post operative

    Measured: 6 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start1 Aug 2020
  3. Primary completion1 Feb 2021
  4. Study completion1 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04617652
Sponsor's protocol ID
R142
Status last verified
Aug 2021
First submitted
23 Oct 2020
Last updated
19 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Magnesium sulfate and Normal saline in people with Smooth Extubation, run by Fayoum University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

smoothness of extubation (time frame: Procedure (At time of extubation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.

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