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Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects

Primary Purpose

Tachycardia

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
0.5 µg/kg remifentanil
1.0 µg/kg remifentanil
NaCl
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachycardia focused on measuring remifentanil, anesthesia induction, reactional tachycardia

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients requiring rapid sequence intubation for whatever reason. This includes the following: a full stomach, obesity, diabetic gastroparesis, gastroesophageal reflux
  • Patient able to give informed consent, and sign the consent.

Exclusion Criteria:

  • Contraindication for the use of any drugs used (regardless of the patient group): a history of serious side effects, allergic reaction
  • Morbid obesity (Body Mass Index > 40)
  • Emergency situation with unstable hemodynamics, and stabilization is impossible before induction
  • Inclusion in another research project within the past 3 months
  • The patient is not insured or beneficiary of a health insurance plan (for the French centers)
  • Patient under guardianship of any kind
  • Patient unable to give informed consent
  • Refusal to sign the consent form

Sites / Locations

  • Centre Hospitalier Universitaire de Nîmes
  • Polyclinique Grand Sud

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

0.5 µg / kg remifentanil

1.0 µg/kg remifentanil

NaCl

Arm Description

Induction anesthesia includes 0.5 µg/kg remifentanil in addition to classic induction anesthesia protocol.

Induction anesthesia includes 1.0 µg/kg remifentanil in addition to the classic induction protocol.

An equivalent volume (1 ml for 10 kg of weight) of isotonic 0.9% NaCl is injected in addition to the classic anesthesia induction protocol

Outcomes

Primary Outcome Measures

Cardiac frequency (beats per minute)
Patient cardiac frequency (beats per minute) at the time of induction

Secondary Outcome Measures

Full Information

First Posted
December 13, 2010
Last Updated
March 14, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01259648
Brief Title
Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects
Official Title
Randomized Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 9, 2011 (Actual)
Primary Completion Date
May 20, 2014 (Actual)
Study Completion Date
May 20, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to determine whether, during a rapid sequence intubation by etomidate, and succinylcholine Sellick maneuver, the administration of remifentanil at 2 different dosages (0.5 and 1.0 microgram per kg body weight), reduces potentially dangerous reactional tachycardia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia
Keywords
remifentanil, anesthesia induction, reactional tachycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5 µg / kg remifentanil
Arm Type
Experimental
Arm Description
Induction anesthesia includes 0.5 µg/kg remifentanil in addition to classic induction anesthesia protocol.
Arm Title
1.0 µg/kg remifentanil
Arm Type
Experimental
Arm Description
Induction anesthesia includes 1.0 µg/kg remifentanil in addition to the classic induction protocol.
Arm Title
NaCl
Arm Type
Placebo Comparator
Arm Description
An equivalent volume (1 ml for 10 kg of weight) of isotonic 0.9% NaCl is injected in addition to the classic anesthesia induction protocol
Intervention Type
Drug
Intervention Name(s)
0.5 µg/kg remifentanil
Intervention Description
0.5 µg/kg remifentanil is used during induction in addition to the classic induction protocol
Intervention Type
Drug
Intervention Name(s)
1.0 µg/kg remifentanil
Intervention Description
1.0 µg/kg remifentanil is added to the classic induction anesthesia protocol
Intervention Type
Drug
Intervention Name(s)
NaCl
Intervention Description
an equivalent volume (1 ml for 10 kg of weight) of 0.9% isotonic NaCl is injected in addition to the classic anesthesia induction protocol
Primary Outcome Measure Information:
Title
Cardiac frequency (beats per minute)
Description
Patient cardiac frequency (beats per minute) at the time of induction
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients requiring rapid sequence intubation for whatever reason. This includes the following: a full stomach, obesity, diabetic gastroparesis, gastroesophageal reflux Patient able to give informed consent, and sign the consent. Exclusion Criteria: Contraindication for the use of any drugs used (regardless of the patient group): a history of serious side effects, allergic reaction Morbid obesity (Body Mass Index > 40) Emergency situation with unstable hemodynamics, and stabilization is impossible before induction Inclusion in another research project within the past 3 months The patient is not insured or beneficiary of a health insurance plan (for the French centers) Patient under guardianship of any kind Patient unable to give informed consent Refusal to sign the consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Chaumeron, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Nîmes
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Facility Name
Polyclinique Grand Sud
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data available upon request.

Learn more about this trial

Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects

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