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

NCT05880693 | Completed Phase 1 DMC

• 1 other identifier: Sameh
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours postoperative period

Study Arms (2)

group 1

EXPERIMENTAL

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 2

EXPERIMENTAL

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

Interventions

Dexmedetomidine DRUG

Group 1 received dexmedetomidine

Also known as: magnesium sulfate

group 1

Magnesium sulfate DRUG

the group 2 received magnesium sulfate

group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• ASA (American Society of Anesthesiologists) grading I and II
• patients undergo rhinoplasty surgery under general anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• mohamed: lead
• Al-Azhar University: collaborator

Study Sites (1)

Mohamed gawad Abdel aboelsuod

Cairo, Egypt

Location

MeSH Terms

Conditions

Hypotension

Interventions

Dexmedetomidine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Mohamed GA aboelsuod

  AZHAR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assissant professor of anesthesia

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 30, 2023
• Study Start: January 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

EG (1)