Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery
Information source: University Hospital, Clermont-Ferrand
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tooth Extractions
Intervention: Remifentanil (Drug)
Phase: Phase 4
Sponsored by: University Hospital, Clermont-Ferrand
Official(s) and/or principal investigator(s):
Sophie Gonnu-Levallois, Principal Investigator, Affiliation: University Hospital, Clermont-Ferrand
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
Official title: Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Morphine consumption in Post Anaesthesia Care Unit ( with intravenous titration given by nurse)
- Postoperative pain (measured by the numeric pain intensity scale)
Length of stay in Post Anaesthesia Care Unit and in ambulatory surgery unit
- Occurrence of postoperative nausea and vomiting
additional workload for nurses
postoperative analgesic requirement in the first 48 hours after surgery
percentage of Glottic opening (POGO) score, Cormack-Lehane grading
tolerance of the procedure
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
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
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.
Minimum age: 15 Years.
Maximum age: 35 Years.
- -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
- Obesity (Body mass index > 30 kg. m-²)
- Contraindication for nitrous oxide inhalation
- Patient refusal
Locations and Contacts
CHU Clermont-Ferrand, Clermont-Ferrand 63003, France
Starting date: June 2010
Last updated: July 4, 2014