Tooth ExtractionsPhase 4SUF-REM-DDSNCT01139671
Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery
A Phase 4 study testing Remifentanil in people with Tooth Extractions, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Tooth Extractions
- What is being tested?
- Remifentanil
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- -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
Who cannot join
- Obesity (Body mass index > 30 kg.m-²)
- Pregnancy
- Contraindication for nitrous oxide inhalation
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Tooth Extractions
- Being tested
- Remifentanil
- 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
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption in Post Anaesthesia Care Unit ( with intravenous titration given by nurse)
Measured: 48 h after the surgery
Secondary outcomes (8)
- Postoperative pain (measured by the numeric pain intensity scale)
Measured: 48 h after the surgery
patient's satisfaction
Measured: 48 h after the surgery
Length of stay in Post Anaesthesia Care Unit and in ambulatory surgery unit
Measured: 48 h after the surgery
- Occurrence of postoperative nausea and vomiting
Measured: 48 h after the surgery
additional workload for nurses
Measured: 48 h after the surgery
postoperative analgesic requirement in the first 48 hours after surgery
Measured: 48 h after the surgery
percentage of Glottic opening (POGO) score, Cormack-Lehane grading
Measured: 48 h after the surgery
tolerance of the procedure
Measured: 48 h after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Gonnu-Levallois, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139671
- Sponsor's protocol ID
- CHU-0074
- Other IDs
- 2010-018751-10
- Acronym
- SUF-REM-DDS
- Status last verified
- Jul 2014
- First submitted
- 4 Jun 2010
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT01139671
- Acronym / sponsor ID
- SUF-REM-DDS / CHU-0074
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- -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
Key exclusion criteria (4 listed)
- Obesity (Body mass index > 30 kg.m-²)
- Pregnancy
- Contraindication for nitrous oxide inhalation
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilWisdom 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. | Drug | – |
Primary outcome
Morphine consumption in Post Anaesthesia Care Unit ( with intravenous titration given by nurse)
Time frame: 48 h after the surgery
8 secondary outcomes
- Postoperative pain (measured by the numeric pain intensity scale)
Time frame: 48 h after the surgery
patient's satisfaction
Time frame: 48 h after the surgery
Length of stay in Post Anaesthesia Care Unit and in ambulatory surgery unit
Time frame: 48 h after the surgery
- Occurrence of postoperative nausea and vomiting
Time frame: 48 h after the surgery
additional workload for nurses
Time frame: 48 h after the surgery
postoperative analgesic requirement in the first 48 hours after surgery
Time frame: 48 h after the surgery
percentage of Glottic opening (POGO) score, Cormack-Lehane grading
Time frame: 48 h after the surgery
tolerance of the procedure
Time frame: 48 h after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Gonnu-Levallois principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil in people with Tooth Extractions, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption in Post Anaesthesia Care Unit ( with intravenous titration given by nurse) (time frame: 48 h after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.