Remifentanil Versus Sufentanil for Intubation Condition Without Myorelaxant

Comparison of Intubation Conditions After Induction With Propofol Associated With a Dose of Remifentanil or Sufentanil in Surgical Tooth Extraction.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01910285

Acronym

REMIDENT

Enrollment

Registered

2013-07-29

Start date

2013-06-30

Completion date

2015-09-30

Last updated

2016-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthetic Induction

Keywords

Anesthetic induction, Intubation conditions, Tooth extraction, Propofol, Sufentanil, Remifentanil

Brief summary

The main objective is the comparison of intubation conditions after anesthetic induction bolus of propofol-sufentanil when compared to injection of propofol-remifentanil in patients undergoing surgery for tooth extraction. Intubation without myorelaxant with propofol and sufentanil is classic but less efficient than induction with curare on achieving perfect intubation conditions. The use of a protocol without curare is sometimes justified for short gestures or when you want to avoid allergia. Remifentanil often provides excellent intubation conditions without myorelaxant. However, remifentanil was never compared to sufentanil in terms of intubating conditions without muscle relaxant.

Interventions

DRUGRemifentanyl - sufentanil placebo

Induction of general anesthesia with 3 mg/kg of propofol combined with 3 µg/kg of remifentanil and 10 ml of isotonic sodium chloride for the double blind. The trachea is then intubated after waiting the time of action of each product.

DRUGSufentanil - remifentanyl placebo

Induction of general anesthesia with 3 mg/kg of propofol combined with 0.3 mg/kg of sufentanil and 25 ml of isotonic sodium chloride for the double blind. The trachea is then intubated after waiting the time of action of each product.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* patients 18 to 60 years * American Society of Anesthesiology (ASA) 1 or 2 * scheduled for surgical tooth extraction under general anesthesia with intubation * signed consent form

Exclusion criteria

* criterion of difficult ventilation or intubation * chronic alcoholism or opiate use * beta-blockers or calcium channel blockers treatment * allergy to paracetamol or ketoprofen * patient under protection of justice

Design outcomes

Primary

Measure	Time frame
Scandinavian Scale of Intubation Conditions (from Viby-Mogensen). The comparison will be made on the percentage of obtaining excellent intubation conditions.	This outcome measure is assessed at day 1 during the per-anesthetic period.

Secondary

Measure	Time frame
percentage of patient with a decrease of over 20% in Mean Arterial Pressure (MAP) or Heart Rate (HR)	This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.
breath - hold time - time to extubation, time to Aldrete score of 10 in PostAnesthesia Care Unit (PACU)	This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.
difficult intubating scale (Adnet et al. Anesthesiology. 99)	This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026