Clinical trial NCT01139671: Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery
Official title: Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Extractions
Keywords: Remifentanil
Sufentanil
Surgical removal of three to four wisdom teeth
General anaesthesia
Ambulatory oral surgery
Target Controlled Infusion (TCI)
Opioid induced hyperalgesia
Postoperative nausea and vomiting
Postoperative Morphine consumption
Under General anaesthesia
In Ambulatory surgery
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 18
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* -age between 15 and 35 years old
* American Society of Anaesthesiologists (ASA) physical status I or II
* Surgical removal of three to four wisdom teeth
* general anaesthesia
* Ambulatory surgery

Exclusion Criteria:

* Obesity (Body mass index \> 30 kg.m-²)
* Pregnancy
* Contraindication for nitrous oxide inhalation
* Patient refusal

Primary outcomes:
measure: Morphine consumption in Post Anaesthesia Care Unit ( with intravenous titration given by nurse)
timeFrame: 48 h after the surgery
Secondary outcomes:
measure: - Postoperative pain (measured by the numeric pain intensity scale)
timeFrame: 48 h after the surgery
measure: patient's satisfaction
timeFrame: 48 h after the surgery
measure: Length of stay in Post Anaesthesia Care Unit and in ambulatory surgery unit
timeFrame: 48 h after the surgery
measure: - Occurrence of postoperative nausea and vomiting
timeFrame: 48 h after the surgery
measure: additional workload for nurses
timeFrame: 48 h after the surgery
measure: postoperative analgesic requirement in the first 48 hours after surgery
timeFrame: 48 h after the surgery
measure: percentage of Glottic opening (POGO) score, Cormack-Lehane grading
timeFrame: 48 h after the surgery
measure: tolerance of the procedure
timeFrame: 48 h after the surgery
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sophie Gonnu-Levallois
role: PRINCIPAL_INVESTIGATOR
References: