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

May 29, 2023 updated by: mohamed

Dexmedetomidine Versus Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • 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 Locations

  • Egypt
      • Cairo, Egypt
        • Mohamed gawad Abdel aboelsuod

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 18-60 years old
  2. ASA (American Society of Anesthesiologists) grading I and II
  3. patients undergo rhinoplasty surgery under general anesthesia

Exclusion Criteria:

  1. The pregnant ladies
  2. patients suffering from hypertension ischemic heart diseases renal insufficiency, neuromuscular diseases, hepatic impairment
  3. cerebrovascular inadequacy and diabetic neuropathy, coagulopathies,
  4. patients taking antiplatelets
  5. Refused study,
  6. patients of age < 18 or > 60 were unauthorized from the study.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1

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.

.
Drug: Dexmedetomidine
Group 1 received dexmedetomidine
Other Names:
  • magnesium sulfate
Experimental: group 2
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
Drug: Magnesium sulfate
the group 2 received magnesium sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome was to determine the bleeding score
Time Frame: 24 hours postoperative period
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.
24 hours postoperative period

Collaborators and Investigators

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

Sponsor

mohamed

Collaborators

Azhar University

Investigators

  • Principal Investigator: Mohamed GA aboelsuod, AZHAR

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)

January 1, 2022

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sameh

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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