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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018751-10 | EudraCT Number |
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Wisdom teeth removal under general anaesthesia is usually suitable for ambulatory surgery.
The choice of opioid in dental day surgery is based on the need for a rapid and full recovery, as well as less morphine administration. Whether remifentanil can achieve these goals remains to be proved, especially regarding remifentanil-induced hyperalgesia, the potential prolonged Post Anesthesia Care Unit (PACU) stay, or remifentanil-induced workload for nurses.
Patients will be enrolled during the preoperative anaesthetic assessment. Premedication will be achieved with oral administration of hydroxyzine 1 mg/kg the morning before surgery.
The induction of general anaesthesia will be achieved using TARGET CONTROLLED INFUSION (TCI) of propofol associated to TCI of remifentanil or sufentanil, depending on randomization.
The conditions of endotracheal intubation will be evaluated by the Percentage Of Glottic Opening Score (POGO) and the Cormack and Lehane Score.
Mechanical volume-controled ventilation will aim to maintain normocapnia. The baseline inspiratory gas will be a mixture of 45% oxygen and 55% nitrous oxide.
Bispectral Index recording and vital signs monitoring (heart rate and arterial blood pressure) will be used to monitor the depth of anaesthesia.
Dexamethasone 0.3 mg/kg will be administered after induction of general anaesthesia as part of our routine practice.
Patients will be extubated as soon as possible after the end of the surgery and transferred to the PACU.
Nurses in charge patients included in the study will be blinded to the opiod agent administered peroperatively.
Postoperative pain will be assessed using the simple numeric scale. A pain score above 3/10 will prompt the intravenous administration of titrated morphine chlorhydrate, as guided by a written protocol.
Patient will be transferred from the PACU to the ambulatory surgery unit when the Aldrete score is greater or equal to 9. Every patient included will received 1 gr of intravenous paracetamol two hours after the arrival hour in the PACU.
Pain monitoring will be continued in the ambulatory surgery unit, and morphine chlorhydrate will be orally administered (10 mg) if pain score is above 3/10.
Post anaesthetic discharge for home readiness will be given when the Post Anesthetic Discharge Scoring System (PADSS) is greater or equal to 9.
48 hours after the surgery, one of us, blinded to the opiod agent received by the patient, will contact every included patient by phone, in order to evaluate postoperative pain, potential side effects including nausea and vomiting, and patient satisfaction.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | Wisdom teeth removal under general anaesthesia is usually suitable for ambulatory surgery. The choice of opioid in dental day surgery is based on the need for a rapid and full recovery, as well as less morphine administration. Whether remifentanil can achieve these goals remains to be proved, especially regarding remifentanil-induced hyperalgesia, the potential prolonged Post Anesthesia Care Unit (PACU) stay, or remifentanil-induced workload for nurses. |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption in Post Anaesthesia Care Unit ( with intravenous titration given by nurse) | 48 h after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| - Postoperative pain (measured by the numeric pain intensity scale) | 48 h after the surgery | |
| patient's satisfaction | 48 h after the surgery | |
| Length of stay in Post Anaesthesia Care Unit and in ambulatory surgery unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Gonnu-Levallois | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 48 h after the surgery |
| - Occurrence of postoperative nausea and vomiting | 48 h after the surgery |
| additional workload for nurses | 48 h after the surgery |
| postoperative analgesic requirement in the first 48 hours after surgery | 48 h after the surgery |
| percentage of Glottic opening (POGO) score, Cormack-Lehane grading | 48 h after the surgery |
| tolerance of the procedure | 48 h after the surgery |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |