Stress ResponseNCT04544163
Magnesium Versus High Dose Fentanyl in Endotracheal Intubation
A study testing Magnesium sulfate- Fentanyl, Fentanyl 4Mcg/kg and Fentanyl 2Mcg/kg in people with Stress Response, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
this study is designed to assess the efficacy of MgSO4 versus high dose fentanyl compared to conventional anesthesia in attenuating stress response to intubation Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stress Response
- What is being tested?
- Magnesium sulfate- Fentanyl, Fentanyl 4Mcg/kg and Fentanyl 2Mcg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2020to 5 May 2021
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cancer patients undergoing surgery under general anesthesia requiring endotracheal intubation
- ASA I II
- 18 to 60
Who cannot join
- allergy to any of the used drugs
- renal or hepatic impairment
- hypertensive patients, patients with cardiovascular or cerebrovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnesium Versus High Dose Fentanyl in Attenuating Stress Response to Endotracheal Intubation
this study is designed to assess the efficacy of MgSO4 versus high dose fentanyl compared to conventional anesthesia in attenuating stress response to intubation
Read the detailed description
to assess the effect of MgSO4 combined with fentanyl compared to high dose fentanyl in attenuating stress response in cancer patients undergoing surgeries under general anesthesia requiring endotracheal intubation
- Conditions
- Stress Response
- Being tested
- Magnesium sulfate- Fentanyl, Fentanyl 4Mcg/kg, Fentanyl 2Mcg/kg, Lidocaine 1.5 mg/kg
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfate- FentanylDrug
Also called MgSo4
drug administration before intubation
Fentanyl 4Mcg/kgDrug
Also called high dose fentanyl
drug administration with induction of anesthesia
Fentanyl 2Mcg/kgDrug
Also called Conventional anesthesia
drug administration with induction of anesthesia
Lidocaine 1.5 mg/kgDrug
Also called Lidocaine
drug administaration 90 sec before intubation
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulphate- Fentanyl | Experimental | 30 mg per kg MgSo4 infusion in 100 ml saline over 10 minutes Receives: Drug: Magnesium sulfate- Fentanyl; Drug: Fentanyl 2Mcg/kg |
| Fentanyl 4 mic | Experimental | 4 mic per kg fentanyl i.v Receives: Drug: Fentanyl 4Mcg/kg |
| Fentanyl | Active comparator | 2 mic per kg fentanyl i.v Receives: Drug: Fentanyl 2Mcg/kg |
| Lidocaine- Fentanyl | Experimental | Lidocaine 1.5 mg/kg Receives: Drug: Fentanyl 2Mcg/kg; Drug: Lidocaine 1.5 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate values
changes in heart rate values after intubation
Measured: 5 minutes
Secondary outcomes (2)
blood pressure
mean arterial blood pressure values
Measured: 5 minutes
coughing during intubation
coughing during intubation
Measured: lntubation time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start5 Sep 2020
- Primary completion2 May 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ResponseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- Walaa Y Elsabeeny, MD, Principal investigator, LecturerNahla N Shehab, MD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544163
- Sponsor's protocol ID
- AP2007-50108
- Status last verified
- May 2021
- First submitted
- 3 Sep 2020
- Last updated
- 11 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be available upon reasonable request through contacting the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Versus High Dose Fentanyl in Attenuating Stress Response to Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT04544163
- Acronym / sponsor ID
- AP2007-50108
- Conditions
- Stress Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 5 Sep 2020 (actual)
- Primary completion
- 2 May 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 10 Sep 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.
this study is designed to assess the efficacy of MgSO4 versus high dose fentanyl compared to conventional anesthesia in attenuating stress response to intubation
Detailed description
to assess the effect of MgSO4 combined with fentanyl compared to high dose fentanyl in attenuating stress response in cancer patients undergoing surgeries under general anesthesia requiring endotracheal intubation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulphate- Fentanyl | Experimental | Drug: Magnesium sulfate- Fentanyl, Drug: Fentanyl 2Mcg/kg30 mg per kg MgSo4 infusion in 100 ml saline over 10 minutes |
| Fentanyl 4 mic | Experimental | Drug: Fentanyl 4Mcg/kg4 mic per kg fentanyl i.v |
| Fentanyl | Active comparator | Drug: Fentanyl 2Mcg/kg2 mic per kg fentanyl i.v |
| Lidocaine- Fentanyl | Experimental | Drug: Fentanyl 2Mcg/kg, Drug: Lidocaine 1.5 mg/kgLidocaine 1.5 mg/kg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Cancer patients undergoing surgery under general anesthesia requiring endotracheal intubation
- ASA I II
- 18 to 60
Key exclusion criteria (3 listed)
- allergy to any of the used drugs
- renal or hepatic impairment
- hypertensive patients, patients with cardiovascular or cerebrovascular diseases
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 sulfate- FentanylAlso: MgSo4drug administration before intubation | Drug | Magnesium sulphate- Fentanyl |
| Fentanyl 4Mcg/kgAlso: high dose fentanyldrug administration with induction of anesthesia | Drug | Fentanyl 4 mic |
| Fentanyl 2Mcg/kgAlso: Conventional anesthesiadrug administration with induction of anesthesia | Drug | Fentanyl, Lidocaine- Fentanyl, Magnesium sulphate- Fentanyl |
| Lidocaine 1.5 mg/kgAlso: Lidocainedrug administaration 90 sec before intubation | Drug | Lidocaine- Fentanyl |
Primary outcome
heart rate values
Time frame: 5 minutes
changes in heart rate values after intubation
2 secondary outcomes
blood pressure
Time frame: 5 minutes
coughing during intubation
Time frame: lntubation time
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 11 May 2021.
- Individual participant dataSharing planned: Yes. data will be available upon reasonable request through contacting the corresponding author
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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.
Walaa Y Elsabeeny, MD principal investigator
Lecturer
Nahla N Shehab, MD principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate- Fentanyl, Fentanyl 4Mcg/kg and Fentanyl 2Mcg/kg in people with Stress Response, run by National Cancer Institute, Egypt 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 3 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 11 May 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
heart rate values (time frame: 5 minutes). 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 11 May 2021.