Anesthesia, Local
Conditions
Brief summary
Propofol with remifentanil provides good operative conditions for pediatric cochlear implant (CI); however, large doses of remifentanil usually result in postoperative hyperalgesia and increase postoperative pain. Local anesthesia (LA) is commonly used as an adjunct to general anesthesia in children; however, otologists are usually reluctant in the use of LA as it can cause abolishment of the electrical stapedial reflex threshold (ESRT).
Detailed description
Seventy children (1-6 years) undergoing CI were recruited. Children were divided into two groups. The LA group received subcutaneous infiltration of 0.5 ml/kg lidocaine 1% in adrenaline 1:200,000 and the CT group received 0.5 ml/kg of Na CI 0.9% in adrenaline 1:200,000. The primary outcome was number of patients requiring rescue analgesia (tramadol) during the first 24-h postoperative. Secondary outcomes were haemodynamic variables, the ESRT, intraoperative anesthetic requirements, time to LMA removal, time to total recovery, pain scores, time to first rescue analgesia and incidence of vomiting.
Interventions
DRUGLidocaine 1%/Epi 1:200000
Five minutes before skin incision, subcutaneous infiltration of 0.5 ml/kg of Lidocaine 1%/Epi 1:200000 Inj along a 3 cm extended endaural incision with a 23 G hypodermic needle administered was performed by the surgeon, who was blinded to the applied drug solution.
OTHERNa Cl 0.9%/Epi 1:200000
Five minutes before skin incision, subcutaneous infiltration of 0.5 ml/kg of Na CI 0.9%/Epi 1:200000 inj along a 3 cm extended endaural incision with a 23 G hypodermic needle administered was performed by the surgeon, who was blinded to the applied drug solution.
Sponsors
Bahteem Specialized Hospital
Wahba bakhet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* ASA I-II physical status, * age between 1 and 6 year,
Exclusion criteria
* known allergy to local anesthetics, * predicted operative difficulty (i.e. syndromic hearing loss, congenital cochlear abnormalities or cochlear ossification.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients requiring rescue opioid analgesia (Tramal) | During the length of hospital stay post surgery (on average 24 hours) | Post-operative Pain assessed by the pediatric observational Faces, Legs, Activity, Cry Consolability (FLACC) score with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The anesthesia time. | Intraoperative | Minutes |
| Heart rate | Intraoperative | beats per minute |
| The operative time | Intraoperative | Minutes |
| ESRT responses | Intraoperative | The surgeon assessed ESRT response at the basal, middle, and apical areas of the electrode array by visual monitoring of the stapedius muscle using direct microscopic examination |
| Anesthetic consumption | Intraoperative | propofol and remifentanil requirement after the bolus |
| mean arterial blood pressure | Intraoperative | mm Hg |
Countries
Egypt
Outcome results
None listed