Postoperative Complications Clinical Trial
— ANNAOfficial title:
Autonomous Nervous System Regulated Anaesthesia: A Randomized Controlled Trial Comparing Dexmedetomidine and Placebo in Heart Rate Variability Monitored Children
The goal of this randomized, double blinded study is to examine in children whether postoperative agitation can be reduced. The main question it aims to answer is Will optimized, monitor guided analgesic treatment and dexmedetomidine reduce postoperative agitation Participants will receive a standard anaesthesia regimen and on top of that, a titrable remifentanil infusion guided via Mdoloris Anastasia nociception index (ANI) monitor will be added. Additionally, the patients will receive either bolus placebo or bolus dexmedetomidine. The postoperative agitation measured via the Richmond agitation and sedation scale (RASS) score, will be compared. Secondary outcome measures including carbon dioxide trends will be made.
Status | Not yet recruiting |
Enrollment | 220 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 6 Years |
Eligibility | Inclusion Criteria - Children allocated for general anaesthesia in abdominal and urology setup. - American Association of Anesthesiologists (ASA) score 1-2. - Consent from both parents/legal representatives Exclusion Criteria: - ASA >2 - Missing consent from both parents/legal representatives. - Known allergies or intolerances for remifentanil and dexmedetomidine. - Intubation. - Non fluently Danish speaking/reading parents/representatives |
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark | Odense Patient Data Explorative Network |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Richmond Agitation Sedation Scale Score (RASS) | Nurse evaluation of agitation/sedation on a scale from -5 (deeply sedated) to +4 (highly agitated) | Once within the first minute at entering operating theatre | |
Primary | Richmond Agitation Sedation Scale Score (RASS) | Nurse evaluation of agitation/sedation on a scale from -5 (deeply sedated) to +4 (highly agitated) | Once within the first minute at entering the postoperative care unit (PACU) | |
Primary | Richmond Agitation Sedation Scale Score (RASS) | Nurse evaluation of agitation/sedation on a scale from -5 (deeply sedated) to +4 (highly agitated) | Every 15. minutes while admitted to postoperative care unit (PACU) and until discharge, within a time frame of maximum 240 minutes | |
Secondary | Anaesthesia time consumption | Anaesthesia duration | From the minute of induction of anaesthesia minute of extubation, within a time phrame of 180 minutes | |
Secondary | Postoperative care unit (PACU) time consumption | PACU duration | From the minute of entering PACU area to the minute of discharge from hospital, within a time phrame of 400 minutes | |
Secondary | Total time consumption | Total admission duration | From the minute of induction of anaesthesia to the minute discharge from hospital, within a time phame of 600 minutes | |
Secondary | Total fentanyl dosage | Total dosage of fentanyl from whole hospital stay | From the minute of induction of anaesthesia to the minute discharge from hospital, within a time phame of 600 minutes | |
Secondary | total remifentanil dosage | Total dose remifentanyl infusion + boluses | From the minute of induction of anaesthesia to the minute discharge from hospital, within a time phame of 600 minutes | |
Secondary | Postoperative Nausea and vomiting (PONV) in Postoperative Care Unit (PACU) | One maximum score within a 0 - 2 scale, "2" represents most PONV | From the minute of entering the PACU area to the minute of discharge from hospital, time phrame of maximum 400 minutes | |
Secondary | Postoperative Nausea and vomiting (PONV) after discharge | One maximum score within a 0 - 2 scale during the first 24 hours after discharge. "2" represents most nausea. | From the minute of discharge from hospital until 24 hours after discharge from hospital. Time phrame of maximum 24 hours. | |
Secondary | Nurse - numeric Rating Score (nNRS) | Scale from 1-10 and "10" represents most pain. One maximum score for the entire postoperative care unit (PACU) stay | From the minute of entering the PACU area to the minute of discharge from hospital, a time phrame of maximum 400 minutes | |
Secondary | Parent - Numeric Rating Scale (pNRS) | Scale from 1-10, "10" is most pain. Maximum NRS estimated by parents | From the minute of discharge from hospital until 24 hours after discharge from hospital. Time phrame of maximum 24 hours. | |
Secondary | Face Leggs Agitation Cry Consolidation (FLACC) scale score | One maximum score, 0-10 points, 10 points represents most pain state | From the minute of entering the PACU area to the minute of discharge from hospital, a time phrame of maximum 400 minutes | |
Secondary | Paediatric Emergency Delirium Scale Score (PAED) scale score | One maximum score, 0-18 points, 18 points represents most delirium. Scoring done once during entire postoperative care unit (PACU) stay. | From the minute of entering the PACU area to the minute of discharge from hospital, a time phrame of maximum 400 minutes | |
Secondary | Paracetamol dosage | Total dose paracetamol given in relation to the anesthesia, both premedication and what is given from caretakers in hospital and parents the following day. | From admission to hospital until 24 hours after anesthesia, maximum of two days | |
Secondary | Voltaren dosage | Total dose paracetamol given in relation to the anesthesia, both premedication and what is given from caretakers in hospital and parents the following day. | From admission to hospital until 24 hours after anesthesia, time phrame of maximum of two days | |
Secondary | Other analgesics dosage | Total dose of miscellaneous medications given in relation to the procedure/anesthesia | From admission to hospital until 24 hours after anesthesia, time phrame of maximum of two days | |
Secondary | Propofol dosage | Total dosage propofol given in relation to the anaesthesia | From the minute of induction of anaesthesia until care overtaken by postoperative care (PACU) nurses, within a time frame of 400 minutes | |
Secondary | events | Events during anesthesia: cough, movement, incision, extra fentanyl administration, bolus remifentanil, ANI < 50, suture, extubation, other | During anaeshtesia between induction and extubation, within a time frame of maximum 400 minutes | |
Secondary | Carbondioxide tensions | End-Tidal carbondioxide tension during anaeshtesia | Every five minutes during anaestesia, between induction and extubation, within a time phrame of maximum 400 minutes |
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