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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Completed

CT.gov ID

NCT01259648

Collaborator

(none)

Enrollment

Locations

Arms

38.4

Actual Duration (Months)

37.5

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tachycardia	Drug: 0.5 µg/kg remifentanil Drug: 1.0 µg/kg remifentanil Drug: NaCl	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 9, 2011

Actual Primary Completion Date :

May 20, 2014

Actual Study Completion Date :

May 20, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.5 µg / kg remifentanil Induction anesthesia includes 0.5 µg/kg remifentanil in addition to classic induction anesthesia protocol.	Drug: 0.5 µg/kg remifentanil 0.5 µg/kg remifentanil is used during induction in addition to the classic induction protocol
Experimental: 1.0 µg/kg remifentanil Induction anesthesia includes 1.0 µg/kg remifentanil in addition to the classic induction protocol.	Drug: 1.0 µg/kg remifentanil 1.0 µg/kg remifentanil is added to the classic induction anesthesia protocol
Placebo Comparator: NaCl 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	Drug: NaCl 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

Arm

Intervention/Treatment

Experimental: 0.5 µg / kg remifentanil

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

Drug: 0.5 µg/kg remifentanil

0.5 µg/kg remifentanil is used during induction in addition to the classic induction protocol

Experimental: 1.0 µg/kg remifentanil

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

Drug: 1.0 µg/kg remifentanil

1.0 µg/kg remifentanil is added to the classic induction anesthesia protocol

Placebo Comparator: NaCl

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

Drug: NaCl

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

Outcome Measures

Primary Outcome Measures

Cardiac frequency (beats per minute) [15 minutes]
Patient cardiac frequency (beats per minute) at the time of induction

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Nîmes	Nîmes	Gard	France	30029
2	Polyclinique Grand Sud	Nîmes	Gard	France	30029

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator: Arnaud Chaumeron, MD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT01259648

Other Study ID Numbers:

LOCAL/2009/AC-02
2009-018169-12

First Posted:

Dec 14, 2010

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Centre Hospitalier Universitaire de Nīmes

remifentanil

anesthesia induction

reactional tachycardia

Additional relevant MeSH terms:

Tachycardia

Remifentanil

Study Results

No Results Posted as of Mar 29, 2022