Clinical trial NCT05634148: Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery
Official title: Effect of a Single Dose Infusion of Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery - a Randomised Contolled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Delirium
Lead sponsor: Security Forces Hospital
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 42
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Riker sedation-agitation score
timeFrame: 60 minutes
Secondary outcomes:
measure: Postoperative pain score
timeFrame: 60 minutes
measure: Opioid consumption
timeFrame: 60 minutes
measure: Adverse events
timeFrame: 60 minutes
measure: Duration of stay in PACU
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Security Forces Hospital
Study officials:
affiliation: Security Forces Hospital
name: Anwar Huda, FRCA
role: PRINCIPAL_INVESTIGATOR
References: