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

NCT ID: NCT05880693

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-05-01

Brief Summary

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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

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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.

Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
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 Groups

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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.

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Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Group 1 received dexmedetomidine

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

Group Type EXPERIMENTAL

Magnesium sulfate

Intervention Type DRUG

the group 2 received magnesium sulfate

Interventions

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Dexmedetomidine

Group 1 received dexmedetomidine

Intervention Type DRUG

Magnesium sulfate

the group 2 received magnesium sulfate

Intervention Type DRUG

Other Intervention Names

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magnesium sulfate

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role collaborator

mohamed

OTHER

Sponsor Role lead

Responsible Party

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mohamed

assissant professor of anesthesia

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed GA aboelsuod

Role: PRINCIPAL_INVESTIGATOR

AZHAR

Locations

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Mohamed gawad Abdel aboelsuod

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Sameh

Identifier Type: -

Identifier Source: org_study_id

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