search
Back to results

Comparisons Between Dexmedetomidine and Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries

Primary Purpose

Hypotension

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Magnesium sulfate
Sponsored by
mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18-60 years old ASA (American Society of Anesthesiologists) grading I and II patients undergo rhinoplasty surgery under general anesthesia Exclusion Criteria: The pregnant ladies patients suffering from hypertension ischemic heart diseases renal insufficiency, neuromuscular diseases, hepatic impairment cerebrovascular inadequacy and diabetic neuropathy, coagulopathies, patients taking antiplatelets Refused study, patients of age < 18 or > 60 were unauthorized from the study.

Sites / Locations

  • Mohamed gawad Abdel aboelsuod

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group 1

group 2

Arm Description

The first group (group 1): (n= 28): Received a loading dose of dexmedetomidine 1 μg/kg in a normal saline 0.9% solution of 100 ml 10 minutes before anesthesia induction and then a 0.4 ug/kg/h via syringe infusion pump during the time of surgery. .

The second group (group 2): (n= 28): Received magnesium sulfate 30 mg/kg as a loading dose in a saline 0.9% solution of 100 ml infusion through the syringe pump10 minutes before anesthesia induction and then a 10 mg/kg/h via syringe infusion pump during the time of surgery

Outcomes

Primary Outcome Measures

The primary outcome was to determine the bleeding score
The primary outcome was to determine the bleeding score, the secondary outcomes included the mean arterial pressure as well as heart rate aiming to arrive at a surgical field free from the blood through controlled Hypotension, determination of surgeon satisfaction, and operation time, they also aided in anesthesia recovery through the use of the Aldrete score, Ramsey sedation score, and the first analgesia postoperative requirement.

Secondary Outcome Measures

Full Information

First Posted
May 18, 2023
Last Updated
May 29, 2023
Sponsor
mohamed
Collaborators
Azhar University
search

1. Study Identification

Unique Protocol Identification Number
NCT05880693
Brief Title
Comparisons Between Dexmedetomidine and Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries
Official Title
Dexmedetomidine Versus Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
mohamed
Collaborators
Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
General anesthesia organizes the best option for controlled blood pressure during rhinoplasty surgery. The primary agent applied in controlling hypotension should have particular unique characteristics. The dexmedetomidine central and peripheral sympatholytic performance is usually indicated by low blood pressure and low heart rate. magnesium sulfate is among the best agents used.
Detailed Description
This is a prospective comparative randomized study. 56 patients got enrolled and then divided into two groups. Group 1 received dexmedetomidine (n=28), while the group 2 received magnesium sulfate (n=28). MAP, as well as heart rate, were recorded. Surgeon satisfaction was approximated for the surgical field quality. The amount of blood loss during the entire process was measured. The score of pain was evaluated using the NRS rating scale. Sedation score through Ramsey sedation score. The time required for the first requirement of analgesia was also recorded as well as intraoperative and postoperative problems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
56 patients got enrolled and then divided into two groups. Group 1 received dexmedetomidine (n=28), while the group 2 received magnesium sulfate (n=28). MAP, as well as heart rate, were recorded. Surgeon satisfaction was approximated for the surgical field quality.
Masking
Investigator
Masking Description
56 patients got enrolled and then divided into two groups. Group 1 received dexmedetomidine (n=28), while the group 2 received magnesium sulfate (n=28). MAP, as well as heart rate, were recorded. Surgeon satisfaction was approximated for the surgical field quality.
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Experimental
Arm Description
The first group (group 1): (n= 28): Received a loading dose of dexmedetomidine 1 μg/kg in a normal saline 0.9% solution of 100 ml 10 minutes before anesthesia induction and then a 0.4 ug/kg/h via syringe infusion pump during the time of surgery. .
Arm Title
group 2
Arm Type
Experimental
Arm Description
The second group (group 2): (n= 28): Received magnesium sulfate 30 mg/kg as a loading dose in a saline 0.9% solution of 100 ml infusion through the syringe pump10 minutes before anesthesia induction and then a 10 mg/kg/h via syringe infusion pump during the time of surgery
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
magnesium sulfate
Intervention Description
Group 1 received dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Description
the group 2 received magnesium sulfate
Primary Outcome Measure Information:
Title
The primary outcome was to determine the bleeding score
Description
The primary outcome was to determine the bleeding score, the secondary outcomes included the mean arterial pressure as well as heart rate aiming to arrive at a surgical field free from the blood through controlled Hypotension, determination of surgeon satisfaction, and operation time, they also aided in anesthesia recovery through the use of the Aldrete score, Ramsey sedation score, and the first analgesia postoperative requirement.
Time Frame
24 hours postoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-60 years old ASA (American Society of Anesthesiologists) grading I and II patients undergo rhinoplasty surgery under general anesthesia Exclusion Criteria: The pregnant ladies patients suffering from hypertension ischemic heart diseases renal insufficiency, neuromuscular diseases, hepatic impairment cerebrovascular inadequacy and diabetic neuropathy, coagulopathies, patients taking antiplatelets Refused study, patients of age < 18 or > 60 were unauthorized from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed GA aboelsuod
Organizational Affiliation
AZHAR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohamed gawad Abdel aboelsuod
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Comparisons Between Dexmedetomidine and Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries

We'll reach out to this number within 24 hrs