Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery (SUF-REM-DDS)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tooth Extractions |
Drug: Remifentanil |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery |
- Morphine consumption in Post Anaesthesia Care Unit ( with intravenous titration given by nurse) [ Time Frame: 48 h after the surgery ] [ Designated as safety issue: Yes ]
- - Postoperative pain (measured by the numeric pain intensity scale) [ Time Frame: 48 h after the surgery ] [ Designated as safety issue: Yes ]
- patient's satisfaction [ Time Frame: 48 h after the surgery ] [ Designated as safety issue: Yes ]
- Length of stay in Post Anaesthesia Care Unit and in ambulatory surgery unit [ Time Frame: 48 h after the surgery ] [ Designated as safety issue: Yes ]
- - Occurrence of postoperative nausea and vomiting [ Time Frame: 48 h after the surgery ] [ Designated as safety issue: Yes ]
- additional workload for nurses [ Time Frame: 48 h after the surgery ] [ Designated as safety issue: Yes ]
- postoperative analgesic requirement in the first 48 hours after surgery [ Time Frame: 48 h after the surgery ] [ Designated as safety issue: Yes ]
- percentage of Glottic opening (POGO) score, Cormack-Lehane grading [ Time Frame: 48 h after the surgery ] [ Designated as safety issue: Yes ]
- tolerance of the procedure [ Time Frame: 48 h after the surgery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
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Drug: Remifentanil
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.
Eligibility| Ages Eligible for Study: | 15 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Patrick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| France | |
| CHU Clermont-Ferrand | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr | |
| Principal Investigator: | Sophie Gonnu-Levallois | University Hospital, Clermont-Ferrand |
More Information
No publications provided
| Responsible Party: | Patrick LACARIN, CHU Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT01139671 History of Changes |
| Other Study ID Numbers: | CHU-0074, 2010-018751-10 |
| Study First Received: | June 4, 2010 |
| Last Updated: | January 18, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
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 |
Additional relevant MeSH terms:
|
Anesthetics Remifentanil Sufentanil Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Analgesics, Opioid |
Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Adjuvants, Anesthesia Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013