Local Anesthesia for Pediatric Cochlear Implant

Phase 4

Completed

• Conditions: Anesthesia, Local

• Registration Number: NCT03721081
• Lead Sponsor: Wahba bakhet

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.

Study Timeline

• Study Start: 2014-08-01
• Primary Completion: 2016-08-26
• Study Completion: 2016-08-26
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-26
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The anesthesia time.	Intraoperative	Minutes
mean arterial blood pressure	Intraoperative	mm Hg
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
Heart rate	Intraoperative	beats per minute
The operative time	Intraoperative	Minutes
Anesthetic consumption	Intraoperative	propofol and remifentanil requirement after the bolus

Trial Locations

Locations (1)

Ainshams University; 🇪🇬 Cairo, Egypt