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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05880693
Other study ID # Sameh
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 1, 2022
Est. completion date May 1, 2023

Study information

Verified date May 2023
Source Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date May 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
Group 1 received dexmedetomidine
Magnesium sulfate
the group 2 received magnesium sulfate

Locations

Country Name City State
Egypt Mohamed gawad Abdel aboelsuod Cairo

Sponsors (2)

Lead Sponsor Collaborator
mohamed Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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