NCT01139671

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

1.1 years

First QC Date

June 4, 2010

Last Update Submit

July 4, 2014

Conditions

Tooth Extractions

Keywords

RemifentanilSufentanilSurgical removal of three to four wisdom teethGeneral anaesthesiaAmbulatory oral surgeryTarget Controlled Infusion (TCI)Opioid induced hyperalgesiaPostoperative nausea and vomitingPostoperative Morphine consumptionUnder General anaesthesiaIn Ambulatory surgery

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption in Post Anaesthesia Care Unit ( with intravenous titration given by nurse)

    48 h after the surgery

Secondary Outcomes (8)

  • - Postoperative pain (measured by the numeric pain intensity scale)

    48 h after the surgery

  • patient's satisfaction

    48 h after the surgery

  • Length of stay in Post Anaesthesia Care Unit and in ambulatory surgery unit

    48 h after the surgery

  • - Occurrence of postoperative nausea and vomiting

    48 h after the surgery

  • additional workload for nurses

    48 h after the surgery

  • +3 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Obesity (Body mass index \> 30 kg.m-²)
  • Pregnancy
  • Contraindication for nitrous oxide inhalation
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sophie Gonnu-Levallois

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 8, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

FR(1)