Magnesium Sulphate, Dexemeditomedine and Emergency Agitation
agitation
Magnesium Sulphate vs Dexmedetomidine in Prevention of Emergence Agitation in Adults After Nasal Surgeries.
1 other identifier
interventional
105
1 country
1
Brief Summary
Emergence agitation is a postanesthetic phenomenon that develops in the early phase of general anesthesia recovery, and is characterized by agitation, confusion, disorientation, and possible violent behavior. Though agitation is observed more frequently in pediatric patients, the incidence in adults has been reported at 4.7% or 21.3%. Emergence agitation can lead to serious consequences such as self-extubation, removal of catheters, hemorrhage, and even severe injuries from falling out of the bed. Furthermore, it may increase the demand on human resources and cause medical staff injuries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 23, 2020
CompletedFirst Posted
Study publicly available on registry
August 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedAugust 28, 2020
August 1, 2020
3 months
August 23, 2020
August 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
post operative emergence agitation
in post anesthetic recovery unit
an hour
Study Arms (3)
dexemedetomidine
EXPERIMENTALdexemedetomidine was administered intravenously after induction of general anesthesia.
magnesium sulphage
ACTIVE COMPARATORmagnesium sulphate was infused through out the surgery after induction of general anaesthesia.
saline
PLACEBO COMPARATORnothing was given just saline during the operation.
Interventions
post surgical agitation prophylaxis
Eligibility Criteria
You may qualify if:
- Both genders
- Aged 20-40 years.
- With American Society of Anesthesiologists (ASA) physical status I or II.
- Nonsmokers.
- BMI less than or equal to 30.
- Elective nasal surgery under general anesthesia in which nasal packing on each side was used postoperatively.
You may not qualify if:
- Patients with history of uncontrolled hypertension.
- Patients with ischemic or valvular heart disease.
- Patients use MAO inhibitors or adrenergic block.
- Cognitive impairment.
- Patients taking antipsychotics.
- Renal insufficiency or liver impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Valley University
Qina, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gad S Gad, MD
South Valley University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical professor
Study Record Dates
First Submitted
August 23, 2020
First Posted
August 28, 2020
Study Start
June 1, 2020
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
August 28, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share