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.
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
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)
- Conditions
- Smooth Extubation
- 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 group | Role | What they receive |
|---|---|---|
| Group M | Active comparator | Magnesium group Receives: Drug: Magnesium sulfate |
| Group C | Placebo comparator | Control group Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoothness of extubation
Smoothness of extubation Grade
- No coughing on endotracheal tube
- Coughing on the tube
- Vomiting
- Laryngospasm
Measured: Procedure (At time of extubation)
Secondary outcomes (27)
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
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
heart rate
hemodynamic parameters
Measured: 5 minutes before induction of anathesia
Mean arterial blood pressure
hemodynamic parameters
Measured: 5 minutes before induction of anathesia
SpO2
hemodynamic parameters
Measured: 5 minutes before induction of anathesia
EtCO2
hemodynamic parameters
Measured: 5 minutes before induction of anathesia
heart rate
hemodynamic parameters
Measured: 5 minutes after induction of anathesia
Mean arterial blood pressure
hemodynamic parameters
Measured: 5 minutes after induction of anathesia
SpO2
hemodynamic parameters
Measured: 5 minutes after induction of anathesia
EtCO2
hemodynamic parameters
Measured: 5 minutes after induction of anathesia
heart rate
hemodynamic parameters
Measured: 10 minutes after induction of anathesia
Mean arterial blood pressure
hemodynamic parameters
Measured: 10 minutes after induction of anathesia
SpO2
hemodynamic parameters
Measured: 10 minutes after induction of anathesia
EtCO2
hemodynamic parameters
Measured: 10 minutes after induction of anathesia
heart rate
hemodynamic parameters
Measured: 15 minutes after induction of anathesia
Mean arterial blood pressure
hemodynamic parameters
Measured: 15 minutes after induction of anathesia
SpO2
hemodynamic parameters
Measured: 15 minutes after induction of anathesia
EtCO2
hemodynamic parameters
Measured: 15 minutes after induction of anathesia
heart rate
hemodynamic parameters
Measured: 20 minutes after induction of anathesia
Mean arterial blood pressure
hemodynamic parameters
Measured: 20 minutes after induction of anathesia
SpO2
hemodynamic parameters
Measured: 20 minutes after induction of anathesia
EtCO2
hemodynamic parameters
Measured: 20 minutes after induction of anathesia
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
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
The duration of surgery
time needed to perform surgery
Measured: 5 minutes after extubation
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
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.
- First posted5 Nov 2020
- Study start1 Aug 2020
- Primary completion1 Feb 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smooth ExtubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atef Mohamed Sayed mahmoud, Fayoum University Hospital
- Investigators
- Atef S Khalil, MD, Principal investigator, Fayoum University Hospitals
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Magnesium Sulphate on Smoothness of Extubation in Patients Undergoing General Anaesthesia With Endotracheal Intubation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04617652
- Acronym / sponsor ID
- R142
- Conditions
- Smooth Extubation
- Keywords
- Magnesium Sulphate, General Anesthesia, Endotracheal Intubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M | Active comparator | Drug: Magnesium sulfateMagnesium group |
| Group C | Placebo comparator | Drug: Normal salineControl group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective surgeries that need endotracheal intubation.
- Duration of surgery 1-3 hours
- ASA Ⅰ-Ⅱ
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfateAlso: Magnesium GroupPatients will receive 1 gm of magnesium in 10 ml over 5 minutes then infusion of 1 gm in 50 ml over one hour. | Drug | Group M |
| Normal salineAlso: Placebo GroupPatients will receive 10 ml of saline, then infusion of 50 ml of normal saline over one hour. | Drug | Group C |
Primary outcome
smoothness of extubation
Time frame: Procedure (At time of extubation)
Smoothness of extubation Grade 1. No coughing on endotracheal tube 2. Coughing on the tube 3. Vomiting 4. Laryngospasm
27 secondary outcomes
sedation score
Time frame: 1 hrs after extubation
sedation score
Time frame: 1 hour after extubation
heart rate
Time frame: 5 minutes before induction of anathesia
Mean arterial blood pressure
Time frame: 5 minutes before induction of anathesia
SpO2
Time frame: 5 minutes before induction of anathesia
EtCO2
Time frame: 5 minutes before induction of anathesia
heart rate
Time frame: 5 minutes after induction of anathesia
Mean arterial blood pressure
Time frame: 5 minutes after induction of anathesia
SpO2
Time frame: 5 minutes after induction of anathesia
EtCO2
Time frame: 5 minutes after induction of anathesia
heart rate
Time frame: 10 minutes after induction of anathesia
Mean arterial blood pressure
Time frame: 10 minutes after induction of anathesia
SpO2
Time frame: 10 minutes after induction of anathesia
EtCO2
Time frame: 10 minutes after induction of anathesia
heart rate
Time frame: 15 minutes after induction of anathesia
Mean arterial blood pressure
Time frame: 15 minutes after induction of anathesia
SpO2
Time frame: 15 minutes after induction of anathesia
EtCO2
Time frame: 15 minutes after induction of anathesia
heart rate
Time frame: 20 minutes after induction of anathesia
Mean arterial blood pressure
Time frame: 20 minutes after induction of anathesia
SpO2
Time frame: 20 minutes after induction of anathesia
EtCO2
Time frame: 20 minutes after induction of anathesia
visual analogue scale (VAS) pain score
Time frame: 4 hours after extubation
visual analogue scale (VAS) pain score
Time frame: 6 hours after extubation
The duration of surgery
Time frame: 5 minutes after extubation
Intraoperative fentanyl needed
Time frame: 5 minutes after extubation
The cumulative opioids (morphine) consumption
Time frame: 6 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
Related trials for Smooth Extubation
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
Not yet recruitingPhase 4
Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation
FESS Operation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atef S Khalil, MD principal investigator
Fayoum University Hospitals
1 site in 1 country: see every site and its status.
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.