Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery

Effect of a Single Dose Infusion of Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery - a Randomised Contolled Trial

Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. The objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of EA and coughing on extubation.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium
• Intervention / Treatment: Drug: Dexmedetomidine

Detailed Description

Emergence agitation (EA) or delirium is a post anesthesia complication which is manifested as confusion, agitation, disorientation and aggressive behavior. It can lead to serious consequences including hemorrhage, removal of lines, drains and catheters, self-extubation and even falling out of bed resulting in severe injuries. EA is associated with cognitive deficit, physical dependence, increased hospital stay and higher mortality.

There is wide variation in the incidence of EA in scientific literature ranging from 5 % to 27.3 %. There are no clear diagnostic criteria for EA because of its varied clinical manifestations. Although many risk factors have been identified including pain, presence of stress at the time of induction, induction with etomidate, use of premedication with benzodiazepines, hypoxemia, type of surgery, awakening in hostile and noisy environment and presence of urinary catheter. Patients undergoing nasal surgeries are in particular, at higher risk for EA due to a sense of suffocation secondary to nasal packing.

Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. The objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of EA and coughing on extubation.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Security Forces Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• We will include patients aged 15 years to 65 years, ASA 1-3 who are planned to undergo general anesthesia for elective nasal surgeries in which nasal packing is used postoperatively

Exclusion Criteria:

• We will exclude patients with known allergy to study medications, BMI more than 35, history of obstructive sleep apnea, history of psychiatric illness, pregnancy and presence of liver and renal diseases.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine group; Patients in this group will receive intravenous dexmedetomidine before extubation	Drug: Dexmedetomidine; Intravenous dexmedetomidine will be administered 45 minutes before extubation in intervention group; Other Names: Control
Placebo Comparator: Control group; Patients in this group will receive intravenous placebo (0.9 % saline) before extubation	Drug: Dexmedetomidine; Intravenous dexmedetomidine will be administered 45 minutes before extubation in intervention group; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Riker sedation-agitation score	Assessment of emergence delirium after extubation. It has numbers from 1-7.	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Morphine equivalent consumption in PACU	60 minutes
Adverse events	Intraoperative or postoperative adverse events	60 minutes
Duration of stay in PACU	duration of PACU stay	60 minutes
Postoperative pain score	Numerical rating scale pain score in PACU. from 0 to 10 with 10 worst pain	60 minutes

Collaborators and Investigators

• Sponsor: Security Forces Hospital
• Investigators: Principal Investigator: Anwar Huda, FRCA, Security Forces Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 1, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium; 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: SFH-Dex Nasal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No