Comparison Between Pregabalin and Magnesium Sulfate in Hy... | NCT05442931

Studies
Comparison Between Pregabalin and Magnesium Sulfate in Hypotensive Anaesthesia

NCT05442931

Sponsor

Minia University

Status

Unknown status

Last Update Posted

Jul 5, 2022Actual

Enrollment

60Estimated

Phase

Phase 1Phase 2

Conditions

Functional Endoscopic Sinus Surgery

Interventions

Pregabalin 150mg
Magnesium Sulfate
Nitroglycerin
surgeon satisfaction

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Oct 30, 2022Estimated

Completion Date

Oct 30, 2022Estimated

First Submitted Date

Mar 25, 2022

First Submission Date that Met QC Criteria

Jun 28, 2022

First Posted Date

Jul 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2022

Last Update Posted Date

Jul 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregabaline	Experimental	Preoperative oral dose of pregabalin for control blood pressure and decrease dose of nitroglycerine consumption	Drug: Pregabalin 150mg
Magnesium sulfate	Experimental	Preoperative intravenous dose for control blood pressure and heart rate	Drug: Magnesium Sulfate
Nitroglycrine	Experimental	Measuring the total dose of nitroglycerine used, using a syringe pump	Drug: Nitroglycerin Other: surgeon satisfaction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin 150mg	Drug	The oral tablet half an hour preoperative 150 milligrams	Pregabaline

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eman Gamal, MD	Contact	01032862852		emangamalhassan2@gmail.com
Sarah Omar, MD	Contact	01005376176		sara.mohamed@mu.edu.eg

Overall Officials

Name	Affiliation	Role
Sarah Omar, M.D.	Minia University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine	Recruiting	Minya		61111	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D000069583	Pregabalin
D008278	Magnesium Sulfate
D005996	Nitroglycerin

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided