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Status unknownNCT05442931Updated Jul 5, 2022

Comparison Between Pregabalin and Magnesium Sulfate in Hypotensive Anaesthesia

A Phase 1/2 interventional study of Pregabalin 150mg and Magnesium Sulfate in Functional Endoscopic Sinus Surgery, sponsored by Minia University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-05.

Sponsored by Minia University · Phase 1/2, Interventional, and Other

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Functional Endoscopic Sinus Surgery
03

In context

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA: class 1 or 2
  • Sex: male and female
  • Age: from 18 to 70 years
  • Patients scheduled for functional endoscopic sinus surgery

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Pregabaline

    Preoperative oral dose of pregabalin for control blood pressure and decrease dose of nitroglycerine consumption

    Drug: Pregabalin 150mg

  • Experimental
    Magnesium sulfate

    Preoperative intravenous dose for control blood pressure and heart rate

    Drug: Magnesium Sulfate

  • Experimental
    Nitroglycrine

    Measuring the total dose of nitroglycerine used, using a syringe pump

    Drug: Nitroglycerin · Other: surgeon satisfaction

Interventions

  • DrugPregabalin 150mg

    The oral tablet half an hour preoperative 150 milligrams

    Also known as: Lyrica 150mg

  • DrugMagnesium Sulfate

    Intravenous administration half an hour preoperative 2 grams

    Also known as: Magnisol 1gm/ 5ml

  • DrugNitroglycerin

    measure total dose of nitroglycerine in milligrams using a syringe pump

    Also known as: Nitronal

  • Othersurgeon satisfaction

    surgeon satisfaction measured according to Likert's scale

    Also known as: surgeon satisfaction Likert's scale

06

What researchers measure

Primary outcomes

  1. Dose of nitroglycerine

    total dose measured by a syringe pump

    Time frame: an hour and half

Secondary outcomes

  1. quality of surgical field

    using Boezaart et al grading scale

    Time frame: an hour and half

  2. surgeon satisfaction

    using Likert's scale

    Time frame: an hour and half

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05442931
Lead sponsor
Minia University
Responsible party
Eman G Hassan , MD (principal investigator, Minia University) — Principal investigator
First posted
Jul 5, 2022
Start date
May 1, 2022
Primary completion
Oct 30, 2022 (estimated)
Completion
Oct 30, 2022 (estimated)
Last update
Jul 5, 2022

Study contacts

Eman Gamal, MD
Contact
emangamalhassan2@gmail.com
01032862852
Sarah Omar, MD
Contact
sara.mohamed@mu.edu.eg
01005376176
Sarah Omar, M.D.
study director · Minia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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