Effect of Dexmedetomidine on Stress Response and Emergence Agitation During Laparoscopic Surgery

NCT02917018 | Completed Phase 2 DMC

• 1 other identifier: Dexmed EA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Emergence agitation is a post-anesthetic phenomenon that develops in the early phase of general anesthesia recovery, and is characterized by agitation, confusion, disorientation, and possible violent behavior. The incidence of emergence agitation is less common in adults as compared to pediatric patients. It may lead to serious consequences for the patient such as bleeding, falling, removal of catheters and self extubation, which lead to further complications like hypoxia and aspiration. Despite its common occurrence, unclear etiology, and serious sequelae, emergence agitation has rarely been studied in adults. The stress response to surgery is an unconscious response to tissue injury. Activation of the sympathetic nervous system, increase of catabolic hormone release and pituitary gland suppression are considered a response to surgical stress, in clinical practice these activities cause changes in heart rate, blood pressure and biochemical fluctuations of noradrenaline, adrenaline, dopamine, and cortisol. Above all, these fluctuations prolong hospitalization and delay patients discharge. Dexmedetomidine is a highly selective alpha-2 receptor agonist having sedative, analgesic and sympatholytic properties. Decreased stress response to surgery ensuring a stable hemodynamic state is a beneficial property of the agent. Peri-operative use of dexmedetomidine also decreases postoperative opioid consumption, pain intensity, and antiemetic therapy. However, the data related to the effects of dexmedetomidine on reducing agitation from general anesthesia in adults are limited.

Conditions

Stress Response

Keywords

Dexmedetomidine; Stress response; Emergence agitation

Outcome Measures

Primary Outcomes (1)

• serum cortisol level

  serum cortisol level will be measured at 2 hours postoperative

  2 hours postoperative

Secondary Outcomes (2)

• post anesthetic emergence agitation

  2 hours postoperative

• visual analogue score

  24 hours postoperative

Study Arms (3)

Dexmedetomidine 1

ACTIVE COMPARATOR

patients will receive dexmedetomidine 1 mic/kg

Drug: Dexmedetomidine

Dexmedetomidine 0.75

ACTIVE COMPARATOR

patients will receive dexmedetomidine 0.75 mic/kg

Drug: Dexmedetomidine

Dexmedetomidine 0.5

ACTIVE COMPARATOR

patients will receive dexmedetomidine 0.5 mic/kg

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Group I will receive 1 ug/kg, group II will receive 0.75 ug/kg and group III will receive 0.5 ug/kg) diluted to 50 ml NaCl 0.9% by syringe pump over 20 minutes before end of surgery.

Dexmedetomidine 0.5; Dexmedetomidine 0.75; Dexmedetomidine 1

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I - II Laparoscopic cholecystectomy under general anesthesia

You may not qualify if:

• Patients with cardiac disease, diabetes. reactive upper airway disease. allergies to dexmedetomidine. cognitive disorders. renal insufficiency. hepatic dysfunction. Chronic use of analgesics, cortisone or drugs known to interact with dexmedetomidine.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Fractures, Stress; Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hamdy Yossef, MD

  assiut university, faculty of medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care, faculty of medicine, Assiut university

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 28, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 4, 2017

Record last verified: 2017-01

Locations

EG (1)