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

Phase 1

Completed

• Conditions: Hypotension
• Interventions: Drug: Dexmedetomidine; Drug: Magnesium sulfate

• Registration Number: NCT05880693
• Lead Sponsor: mohamed

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-04-01
• Status Verified: 2023-05
• Study Completion: 2023-05-01
• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-29
• Study First Posted: 2023-05-30
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	Dexmedetomidine	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. .
group 2	Magnesium sulfate	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mohamed gawad Abdel aboelsuod; 🇪🇬 Cairo, Egypt