Magnesium Sulphate, Dexemeditomedine and Emergency Agitation (agitation)

Magnesium Sulphate vs Dexmedetomidine in Prevention of Emergence Agitation in Adults After Nasal Surgeries.

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Confusion
• Intervention / Treatment: Drug: Dexmedetomidine injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ossama h salman, MD,PhD; Phone Number: +201223001113; Email: ossamas@hotmail.com
• Study Contact Backup: Name: . Ahmed akkaway, MD; Phone Number: 0201223001113; Email: vpgrd@svu.edu.eg

Study Locations

• Egypt
  • Qinā, Egypt
    • Recruiting
    • South Valley University
    • Contact: Gad S Gad, MD; Phone Number: +201099075675; Email: Kmashson@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dexemedetomidine; dexemedetomidine was administered intravenously after induction of general anesthesia.	Drug: Dexmedetomidine injection; post surgical agitation prophylaxis; Other Names: dexemedetomidine
Active Comparator: magnesium sulphage; magnesium sulphate was infused through out the surgery after induction of general anaesthesia.	Drug: Dexmedetomidine injection; post surgical agitation prophylaxis; Other Names: dexemedetomidine
Placebo Comparator: saline; nothing was given just saline during the operation.	Drug: Dexmedetomidine injection; post surgical agitation prophylaxis; Other Names: dexemedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative emergence agitation	in post anesthetic recovery unit	an hour

Collaborators and Investigators

• Sponsor: South Valley University
• Investigators: Study Director: Gad s Gad, MD, South Valley University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: August 23, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Confusion; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: ossamahamdyresearcher6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• 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