Functional Endoscopic Sinus SurgeryPhase 1/2NCT05442931
Comparison Between Pregabalin and Magnesium Sulfate in Hypotensive Anaesthesia
A Phase 1/2 study testing Pregabalin 150mg, Magnesium Sulfate and Nitroglycerin in people with Functional Endoscopic Sinus Surgery, run by Minia University at 1 site in Egypt.
Trial summary
Comparison between pregabalin and magnesium sulfate in hypotensive anaethesia Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functional Endoscopic Sinus Surgery
- What is being tested?
- Pregabalin 150mg, Magnesium Sulfate and Nitroglycerin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 30 Oct 2022
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA: class 1 or 2
- Sex: male and female
- Age: from 18 to 70 years
- Patients scheduled for functional endoscopic sinus surgery
Who cannot join
- Patient on diuretics, corticosteroid, pregabalin
- Patients with a history of allergy to the study drug
- Pregnancy or breastfeeding women Patients with hypertension, cardiac, renal endocrinal diseases
- uncooperative patients (cant does not administer oral tablet)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine
Minya, 61111
Eman Gamal, 01032862852, emangamalhassan2@gmail.com
Sarah Omar, MD, 01005376176, sara.mohamed@mu.edu.eg
About this study
Official title: Comparison Between Single Dose Pregabalin and Magnesium Sulfate in Controlled Hypotension During Functional Endoscopic Sinus Surgery
Comparison between pregabalin and magnesium sulfate in hypotensive anaethesia
Read the detailed description
compare the effect of a single-dose 150 mg oral pregabalin and 2 grams intravenous magnesium sulfate given 30 minutes before induction of anesthesia on the total nitroglycerine used in patients undergoing functional endoscopic sinus surgery
- Conditions
- Functional Endoscopic Sinus Surgery
- Being tested
- Pregabalin 150mg, Magnesium Sulfate, Nitroglycerin, surgeon satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mgDrug
Also called Lyrica 150mg
The oral tablet half an hour preoperative 150 milligrams
Magnesium SulfateDrug
Also called Magnisol 1gm/ 5ml
Intravenous administration half an hour preoperative 2 grams
NitroglycerinDrug
Also called Nitronal
measure total dose of nitroglycerine in milligrams using a syringe pump
surgeon satisfactionOther
Also called surgeon satisfaction Likert's scale
surgeon satisfaction measured according to Likert's scale
| Study group | Role | What they receive |
|---|---|---|
| Pregabaline | Experimental | Preoperative oral dose of pregabalin for control blood pressure and decrease dose of nitroglycerine consumption Receives: Drug: Pregabalin 150mg |
| Magnesium sulfate | Experimental | Preoperative intravenous dose for control blood pressure and heart rate Receives: Drug: Magnesium Sulfate |
| Nitroglycrine | Experimental | Measuring the total dose of nitroglycerine used, using a syringe pump Receives: Drug: Nitroglycerin; Other: surgeon satisfaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of nitroglycerine
total dose measured by a syringe pump
Measured: an hour and half
Secondary outcomes (2)
quality of surgical field
using Boezaart et al grading scale
Measured: an hour and half
surgeon satisfaction
using Likert's scale
Measured: an hour and half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 May 2022
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Endoscopic Sinus SurgeryStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman G Hassan , MD, Minia University
- Investigators
- Sarah Omar, M.D., Study director, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442931
- Sponsor's protocol ID
- 55:2021
- Status last verified
- Jun 2022
- First submitted
- 25 Mar 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Single Dose Pregabalin and Magnesium Sulfate in Controlled Hypotension During Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT05442931
- Acronym / sponsor ID
- 55:2021
- Conditions
- Functional Endoscopic Sinus Surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 5 Jul 2022 (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.
Comparison between pregabalin and magnesium sulfate in hypotensive anaethesia
Detailed description
compare the effect of a single-dose 150 mg oral pregabalin and 2 grams intravenous magnesium sulfate given 30 minutes before induction of anesthesia on the total nitroglycerine used in patients undergoing functional endoscopic sinus surgery
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregabaline | Experimental | Drug: Pregabalin 150mgPreoperative oral dose of pregabalin for control blood pressure and decrease dose of nitroglycerine consumption |
| Magnesium sulfate | Experimental | Drug: Magnesium SulfatePreoperative intravenous dose for control blood pressure and heart rate |
| Nitroglycrine | Experimental | Drug: Nitroglycerin, Other: surgeon satisfactionMeasuring the total dose of nitroglycerine used, using a syringe pump |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA: class 1 or 2
- Sex: male and female
- Age: from 18 to 70 years
- Patients scheduled for functional endoscopic sinus surgery
Key exclusion criteria (4 listed)
- Patient on diuretics, corticosteroid, pregabalin
- Patients with a history of allergy to the study drug
- Pregnancy or breastfeeding women Patients with hypertension, cardiac, renal endocrinal diseases
- uncooperative patients (cant does not administer oral tablet)
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 |
|---|---|---|
| Pregabalin 150mgAlso: Lyrica 150mgThe oral tablet half an hour preoperative 150 milligrams | Drug | Pregabaline |
| Magnesium SulfateAlso: Magnisol 1gm/ 5mlIntravenous administration half an hour preoperative 2 grams | Drug | Magnesium sulfate |
| NitroglycerinAlso: Nitronalmeasure total dose of nitroglycerine in milligrams using a syringe pump | Drug | Nitroglycrine |
| surgeon satisfactionAlso: surgeon satisfaction Likert's scalesurgeon satisfaction measured according to Likert's scale | Other | Nitroglycrine |
Primary outcome
Dose of nitroglycerine
Time frame: an hour and half
total dose measured by a syringe pump
2 secondary outcomes
quality of surgical field
Time frame: an hour and half
surgeon satisfaction
Time frame: an hour and half
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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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.
Sarah Omar, M.D. study director
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pregabalin 150mg, Magnesium Sulfate and Nitroglycerin in people with Functional Endoscopic Sinus Surgery, run by Minia University 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 4 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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Gamal, MD (01032862852, emangamalhassan2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of nitroglycerine (time frame: an hour and half). 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 5 Jul 2022.