Trials / Completed
CompletedNCT04194294
Role of LIDOCAINE IN Pediatric Cochlear Implant Surgery
Intravenous Lidocaine Reduces Remifentanil and Propofol Requirements Without Altering the Electrical Stapedial Reflex Threshold in Pediatric Cochlear Implants
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Wahba bakhet · Academic / Other
- Sex
- All
- Age
- 6 Months – 6 Years
- Healthy volunteers
- Accepted
Summary
The stapedius reflex protects the ear from the loud noise. The measurement of the intraoperative electrically evoked stapedial reflex threshold (ESRT) during pediatric cochlear implants (CIs) is used to confirm that the implant is functioning correctly and determine the maximum comfortable level . Total intravenous anesthesia (TIVA) with propofol and remifentanil is frequently used for pediatric CIs as it does not suppress the ESRT. However, high doses of remifentanil exacerbates postoperative pain and increased opioid consumption.
Detailed description
Total intravenous anesthesia (TIVA) with propofol and remifentanil is frequently used for pediatric CIs as it does not suppress the ESRT. However, high doses of remifentanil exacerbates postoperative pain and increased opioid consumption.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lidocaine | Before induction of anesthesia; children in group LID received an iv bolus dose of LIDOCAINE 1 mg/kg over 5 minutes followed by 1 mg Kg-1 h-1 ivi until the start of skin closure. |
| OTHER | Na CL 0.9% | Before induction of anesthesia; children in group C equivalent volumes of Na Cl 0.9% over the same period instead of LIDOCAINE. |
Timeline
- Start date
- 2015-08-18
- Primary completion
- 2019-06-05
- Completion
- 2019-06-05
- First posted
- 2019-12-11
- Last updated
- 2020-05-01
Source: ClinicalTrials.gov record NCT04194294. Inclusion in this directory is not an endorsement.