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

Sponsor
mohamed (Other)
Overall Status
Completed
CT.gov ID
NCT05880693
Collaborator
Azhar University (Other)
56
Enrollment
1
Location
2
Arms
15.9
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Single (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.
Primary Purpose:
Prevention
Official Title:
Dexmedetomidine Versus Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries
Actual Study Start Date :
Jan 1, 2022
Actual Primary Completion Date :
Apr 1, 2023
Actual Study Completion Date :
May 1, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. The primary outcome was to determine the bleeding score [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mohamed gawad Abdel aboelsuod Cairo Egypt

    Sponsors and Collaborators

    • mohamed
    • Azhar University

    Investigators

    • Principal Investigator: Mohamed GA aboelsuod, AZHAR

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    mohamed, assissant professor of anesthesia, Azhar University
    ClinicalTrials.gov Identifier:
    NCT05880693
    Other Study ID Numbers:
    • Sameh
    First Posted:
    May 30, 2023
    Last Update Posted:
    May 31, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypotension
    Magnesium Sulfate
    Dexmedetomidine

    Study Results

    No Results Posted as of May 31, 2023