Comparison Between Pregabalin and Magnesium Sulfate in Hypotensive Anaesthesia

June 28, 2022 updated by: Eman G Hassan , MD, Minia University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregabaline
Preoperative oral dose of pregabalin for control blood pressure and decrease dose of nitroglycerine consumption
Drug: Pregabalin 150mg
The oral tablet half an hour preoperative 150 milligrams
Other Names:
  • Lyrica 150mg
Experimental: Magnesium sulfate
Preoperative intravenous dose for control blood pressure and heart rate
Drug: Magnesium Sulfate
Intravenous administration half an hour preoperative 2 grams
Other Names:
  • Magnisol 1gm/ 5ml
Experimental: Nitroglycrine
Measuring the total dose of nitroglycerine used, using a syringe pump
Drug: Nitroglycerin
measure total dose of nitroglycerine in milligrams using a syringe pump
Other Names:
  • Nitronal
Other: surgeon satisfaction
surgeon satisfaction measured according to Likert's scale
Other Names:
  • surgeon satisfaction Likert's scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of nitroglycerine
Time Frame: an hour and half
total dose measured by a syringe pump
an hour and half

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of surgical field
Time Frame: an hour and half
using Boezaart et al grading scale
an hour and half
surgeon satisfaction
Time Frame: an hour and half
using Likert's scale
an hour and half

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Study Director: Sarah Omar, M.D., Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Anticipated)

October 30, 2022

Study Completion (Anticipated)

October 30, 2022

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

July 5, 2022

Study Record Updates

Last Update Posted (Actual)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55:2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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