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
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • - 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 ]

Enrollment: 18
Study Start Date: June 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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

Ages Eligible for Study:   15 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139671

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Sophie Gonnu-Levallois University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, 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: July 4, 2014
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
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on October 16, 2014