Remifentanil Versus Sufentanil for Intubation Condition Without Myorelaxant

Phase 4

Completed

• Conditions: Anaesthetic Induction
• Interventions: Drug: Remifentanyl - sufentanil placebo; Drug: Sufentanil - remifentanyl placebo

• Registration Number: NCT01910285
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-29
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-06
• Last Update Posted: 2016-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remifentanyl- sufentanil placebo	Remifentanyl - sufentanil placebo	3 mg/kg of propofol combined with 3 µg/kg of remifentanil
Sufentanil - remifentanyl placebo	Sufentanil - remifentanyl placebo	3 mg/kg of propofol combined with 0.3 mg/kg of sufentanil

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital of Purpan; 🇫🇷 Toulouse, Midi-Pyrénées, France