Magnesium Sulphate, Dexemeditomedine and Emergency Agitation (agitation)
Primary Purpose
Postoperative Confusion
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine injection
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Confusion
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- South Valley UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
dexemedetomidine
magnesium sulphage
saline
Arm Description
dexemedetomidine was administered intravenously after induction of general anesthesia.
magnesium sulphate was infused through out the surgery after induction of general anaesthesia.
nothing was given just saline during the operation.
Outcomes
Primary Outcome Measures
post operative emergence agitation
in post anesthetic recovery unit
Secondary Outcome Measures
Full Information
NCT ID
NCT04531371
First Posted
August 23, 2020
Last Updated
August 25, 2020
Sponsor
South Valley University
1. Study Identification
Unique Protocol Identification Number
NCT04531371
Brief Title
Magnesium Sulphate, Dexemeditomedine and Emergency Agitation
Acronym
agitation
Official Title
Magnesium Sulphate vs Dexmedetomidine in Prevention of Emergence Agitation in Adults After Nasal Surgeries.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Postoperative agitation (POA) although short-lived is potentially harmful to the patient and the recovery staff. In the postoperative care unit, an agitated patient requires more nurses to control his abnormal movement and apply restrains that could result in bruises of his extremities. In the postoperative care unit, we noticed that agitated patients remove venous and arterial catheters, nasal packs, oxygen masks and endotracheal tubes leading to bleeding and hypoxia.
Post-operative agitation is a well-documented phenomenon in children recovering from sevoflurane anesthesia. However, in adults, few reports have highlighted the occurrence of this phenomenon. The exact trigger for this complication remains to be determined, however, many factors play a crucial role in revealing POA. While an alert, calm patient is the ideal recovery outcome, the occurrence of excitation, excessive motor movements and unexplained sounds is not an uncommon scenario following nasal surgery in adults. Several factors have been incriminated to provoke agitations in adults; pain, hypoxia, type of operation, too rapid emergence from anesthesia, sedatives like benzodiazepines.
Post-operative agitation following nasal surgery The incidence of postoperative agitation following nasal surgery is relatively high. The exact mechanism is Unknown. However, some studies reported that the occurrence of POA could be as high as 55.4% and the presence of nasal pack is likely to be the main trigger of agitation. Other experiments reported an incidence of 68% following nasal surgery. We highlighted several factors that may increase the prevalence of POA; Male gender, young age, smoking, postoperative pain and premedication with atropine and Phenergan. Yu et al., 2005 reported a 55% incidence of POA after nasal surgery. They demonstrated that Doxapram administration, pain, and presence of a tracheal tube and or a urinary catheter appear to be the most important causes of postoperative agitation. Similarly, pain, urinary catheters, and tracheal tubes were also reported by Kim et al., 2004as risk factors for POA following nasal surgery. The presence of nasal pack as a trigger to POA remains debatable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Confusion
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dexemedetomidine
Arm Type
Experimental
Arm Description
dexemedetomidine was administered intravenously after induction of general anesthesia.
Arm Title
magnesium sulphage
Arm Type
Active Comparator
Arm Description
magnesium sulphate was infused through out the surgery after induction of general anaesthesia.
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
nothing was given just saline during the operation.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine injection
Other Intervention Name(s)
dexemedetomidine
Intervention Description
post surgical agitation prophylaxis
Primary Outcome Measure Information:
Title
post operative emergence agitation
Description
in post anesthetic recovery unit
Time Frame
an hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ossama H salman, MD,PhD
Phone
+201223001113
Email
ossamas@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
. Ahmed akkaway, MD
Phone
0201223001113
Email
vpgrd@svu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gad S Gad, MD
Organizational Affiliation
South Valley University
Official's Role
Study Director
Facility Information:
Facility Name
South Valley University
City
Qinā
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gad s Gad, MD
Phone
+201099075675
Email
Kmashson@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Magnesium Sulphate, Dexemeditomedine and Emergency Agitation
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