Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery (SUF-REM-DDS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01139671
First received: June 4, 2010
Last updated: July 4, 2014
Last verified: July 2014

June 4, 2010
July 4, 2014
June 2010
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01139671 on ClinicalTrials.gov Archive Site
  • - 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery
Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Tooth Extractions
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.

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
15 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01139671
CHU-0074, 2010-018751-10
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
Not Provided
Principal Investigator: Sophie Gonnu-Levallois University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP