Preoperative Anxiety
Conditions
Keywords
preoperative anxiety, general anesthesia, major surgery, oral melatonin, placebo, premedication
Brief summary
Preoperative anxiety is a common issue in pediatric anesthesia. Children often experience anxiety and uneasiness due to uncertain outcomes. Surgery and anesthesia are among the most traumatic experiences for children, often considered anxiety-inducing medical treatments. Because they lack control over their environment and circumstances, children undergoing medical procedures typically experience significant unease or anxiety. Several studies have reported that 50%-80% of children experience preoperative anxiety. In order to reduce kids anxiety intensity, several measures are utilized. These strategies are either pharmacological, psychological, or behavioural. Benzodiazepines are popular drugs that can reduce anxiety in children. The most used one in premedication is midazolam. It is a rapid-acting benzodiazepine that has a short elimination half-life. It has sedative, anxiolytic, hypnotic, and anterograde amnesic effects. Midazolam, on the other hand, might have a number of negative consequences, including paradoxical reactions, interactions with opioids, excessive sedation, disorientation, and reduced psychomotor performance. Melatonin enhances anti-nociceptive effects, most prominently through the modulation of MT1/MT2 receptors in the brain and spinal cord. In addition, it has been demonstrated that melatonin can interact with additional receptors, including those in the GABAergic system, the nitric oxide (NO)arginine route, the N-Methyl-D-aspartate (NMDA) system, and the dopaminergic system, to produce anti-nociceptive and anti-allodynic effects.
Interventions
DRUGmelatonin (Circadin ®) 0.2 mg/kg
Patients will receive oral melatonin at a dose of 0.2 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.
DRUGmelatonin (Circadin ®) 0.4 mg/kg
Patients will receive oral melatonin at a dose of 0.4 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.
DRUGplacebo group
Patients will receive oral placebo as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.
Sponsors
Al-Ayen Iraqi University
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Patients of either sex * age from 4 to 14 years * Patients with American society Anesthesiologist physical status I and II * Patients undergoing elective surgeries
Exclusion criteria
* ASA more than III * Drug allergy. * Gastrointestinal disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| preoperative anxiety | 24 hours | The child's anxiety level will be assessed by Visual analogue scale-anxiety (VAS-A). The VAS-A consists of a 100 mm horizontal line; the left edge of the line is marked as calm, while the other end shows maximum anxiety. The patients were asked to assess their own anxiety and mark it on the anxiety line. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| preoperative sedation | 24 hours | The sedation level will be assessed using Ramsay Sedation Scale. It divides a patient's level of sedation into six categories ranging from severe agitation at 1 to deep coma at 6. |
Countries
Egypt, Iraq
Contacts
Primary ContactNeveen Kohaf, Ph.D
Outcome results
None listed