Comparison Between Pregabalin and Magnesium Sulfate in Hypotensive Anaesthesia
Comparison Between Single Dose Pregabalin and Magnesium Sulfate in Controlled Hypotension During Functional Endoscopic Sinus Surgery
1 other identifier
interventional
60
1 country
1
Brief Summary
Comparison between pregabalin and magnesium sulfate in hypotensive anaethesia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedFirst Posted
Study publicly available on registry
July 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedJuly 5, 2022
June 1, 2022
6 months
March 25, 2022
June 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Dose of nitroglycerine
total dose measured by a syringe pump
an hour and half
Secondary Outcomes (2)
quality of surgical field
an hour and half
surgeon satisfaction
an hour and half
Study Arms (3)
Pregabaline
EXPERIMENTALPreoperative oral dose of pregabalin for control blood pressure and decrease dose of nitroglycerine consumption
Magnesium sulfate
EXPERIMENTALPreoperative intravenous dose for control blood pressure and heart rate
Nitroglycrine
EXPERIMENTALMeasuring the total dose of nitroglycerine used, using a syringe pump
Interventions
The oral tablet half an hour preoperative 150 milligrams
Intravenous administration half an hour preoperative 2 grams
measure total dose of nitroglycerine in milligrams using a syringe pump
surgeon satisfaction measured according to Likert's scale
Eligibility Criteria
You may qualify if:
- ASA: class 1 or 2
- Sex: male and female
- Age: from 18 to 70 years
- Patients scheduled for functional endoscopic sinus surgery
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Faculty of medicine
Minya, 61111, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sarah Omar, M.D.
Minia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
March 25, 2022
First Posted
July 5, 2022
Study Start
May 1, 2022
Primary Completion
October 30, 2022
Study Completion
October 30, 2022
Last Updated
July 5, 2022
Record last verified: 2022-06