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Cardiac Index and General Anesthesia Without Opioid. (OFFLOW)

Primary Purpose

Hip Arthropathy, Hip Disease

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Dexmedetomidine
Sufentanil
Sponsored by
Centre Hospitalier de Montauban
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hip Arthropathy focused on measuring cardiac index, total hip arthroplasty, opioid free anesthesia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Eligible patients for scheduled total hip arthroplasty with general anesthesia.
  • Patients with an American Society of Anesthesiologists (ASA) score between 1 and 3
  • Patient who has received appropriate information and has provided informed consent.
  • Patient with French social security system.

Exclusion Criteria:

  • Patients eligible to rapid sequence intubation.
  • Patients with medical contraindication to the use of OFA : allergy to one of the drug used in the protocol, spontaneous bradycardia under 40bpm or atrioventricular block.
  • Patients with a medical condition that could alter measurement of cardiac index by NICCOMO™: acute pulmonary oedema, severe valvular heart disease, pulmonary hypertension, atrial fibrillation.
  • Patients who cannot give their informed consent.
  • Patients pregnant or breastfeeding.
  • Patients odler than 90 years old or with a weigh superior at 150kg.

Sites / Locations

  • Edmundo Pereira de Souza NetoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Opioid free anesthesia (OFA)

anesthesia with opioid (OA)

Arm Description

The patients included in the OFA group will receive a bolus of Dexmedetomidine at the beginning of the surgery.

The one in the OA group will be given a bolus of Sufentanil before and during the surgery. When the specific sequence will be completed, the care of all the patient will return to usual.

Outcomes

Primary Outcome Measures

the impact of opioid free anesthesia on the cardiac index
The main objective of this study is to evaluate the impact of opioid free anesthesia on the cardiac index and comparing it to the general anesthesia protocol with opioids.

Secondary Outcome Measures

Assess the impact of the OFA in hemodynamical state
To assess the impact of the OFA protocol on Blood pressure (variation of Blood pressure measured in mmHg)
Assess the impact of the OFA protocol on heart rate
To assess the impact of the OFA protocol on heart rate (variation in heart rate measured in beats per minute)
Assess the impact of OFA on postoperative pain
To assess the impact of OFA on postoperative pain (variation in numeric rating scales) From 0 to 10 => Zero represents "no pain," whereas 10 represents the opposite end of the pain continuum (e.g., "the most intense pain imaginable," "pain as intense as it could be," "maximum pain").
Assess the impact of OFA on the consumption of postoperative morphine
To assess the impact of OFA on the consumption of postoperative morphine (consumption in mg)

Full Information

First Posted
June 19, 2022
Last Updated
February 6, 2023
Sponsor
Centre Hospitalier de Montauban
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1. Study Identification

Unique Protocol Identification Number
NCT05446623
Brief Title
Cardiac Index and General Anesthesia Without Opioid.
Acronym
OFFLOW
Official Title
Comparative Study of General Anesthesia With or Without Opioid on the Cardiac Index During Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 2, 2023 (Anticipated)
Study Completion Date
January 2, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
General anesthesia used to be based on the association of hypnotics and opioid drugs. But recent studies showed that opioids may be related to a many different complications, like respiratory distress, hyperalgesia. Opioid free anesthesia (OFA) aim is to control de cardiovascular nociceptive response to the surgical stimulation. The scientific literature is not clear yet on the cardiovascular effect of the OFA. Optimization of the cardiac index proved its worth in reducing morbidity and mortality. The purpose of this study is to increase our understanding of the impact of opioid free anesthesia on the cardiovascular system and to evaluate the effectiveness and the security of the technic.
Detailed Description
General anesthesia used to be based on the association of hypnotics and opioid drugs. But recent studies showed that opioïds may be related to a many different complications, like respiratory distress, hyperalgesia etc… Those sides effects are known, but there might be some recent technics that could allow anesthesiologist to reduce those unintended symptoms. As surgery became an important pilar of the modern medicine even in fragile people, the weight of opioids sides effect increased. Opioid free anesthesia (OFA) consists in the simultaneous administration of alpha2-agonist (for example the dexmedetomidine (DEXDOR)), sodium channel blocker (lidocaine), and N-methyl-D-aspartate (NMDA) antagonists receptors (Ketamine). Its aim is to control de cardiovascular nociceptive response to the surgical stimulation. The scientific literature is not clear yet on the cardiovascular effect of the OFA. Optimization of the cardiac index proved its worth in reducing morbidity and mortality. The investigators thinks that exploring the impact of two different general anesthesia technics on cardiac index, might allow anesthesiologists to have a better understanding of the anesthetic strategy applied to the patient. General anesthesia with or without opioid is used on a daily basis at the hospital center of Montauban. The possible sides effects of OFA as well as those affiliate to balanced anesthesia are known by all the care workers. The purpose of this study is to increase our understanding of the impact of opioid free anesthesia on the cardiovascular system and to evaluate the effectiveness and the security of the technic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy, Hip Disease
Keywords
cardiac index, total hip arthroplasty, opioid free anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
It is a monocentric, randomized study comparing two strategies of general anesthesia for programmed total hip arthroplasty. Patients who gave their consent for the study during the anesthesia consultation, will be randomized into two groups depending on the type of general anesthesia: Opioid free anesthesia (OFA), or anesthesia with opioid (OA) The patients included in the OFA group will receive a bolus of Dexmedethomidine at the beginning of the surgery. The one in the OA group will be given a bolus of Sufentanil before and during the surgery. When the specific sequence will be completed, the care of all the patient will return to usual. During the anesthesia induction and during the surgery cardiovascular data will be collected. The cardiac index will be measured thanks to a non invasive cardiac monitoring called NICCOMO® (v3.5.2).
Masking
ParticipantInvestigator
Masking Description
Randomized into two groups depending on the type of general anesthesia: Opioid free anesthesia (OFA), or anesthesia with opioid (OA)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Opioid free anesthesia (OFA)
Arm Type
Active Comparator
Arm Description
The patients included in the OFA group will receive a bolus of Dexmedetomidine at the beginning of the surgery.
Arm Title
anesthesia with opioid (OA)
Arm Type
Sham Comparator
Arm Description
The one in the OA group will be given a bolus of Sufentanil before and during the surgery. When the specific sequence will be completed, the care of all the patient will return to usual.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
DEXDOR
Intervention Description
Opioid free anesthesia (OFA) consists in the simultaneous administration of alpha2-agonist (for example the dexmedetomidine), sodium channel blocker (lidocaine), and NMDA antagonists receptors (Ketamine). Its aim is to control de cardiovascular nociceptive response to the surgical stimulation.
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Other Intervention Name(s)
Sufenta
Intervention Description
The one in the OA group will be given a bolus of Sufentanil before and during the surgery.
Primary Outcome Measure Information:
Title
the impact of opioid free anesthesia on the cardiac index
Description
The main objective of this study is to evaluate the impact of opioid free anesthesia on the cardiac index and comparing it to the general anesthesia protocol with opioids.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Assess the impact of the OFA in hemodynamical state
Description
To assess the impact of the OFA protocol on Blood pressure (variation of Blood pressure measured in mmHg)
Time Frame
60 minutes
Title
Assess the impact of the OFA protocol on heart rate
Description
To assess the impact of the OFA protocol on heart rate (variation in heart rate measured in beats per minute)
Time Frame
60 minutes
Title
Assess the impact of OFA on postoperative pain
Description
To assess the impact of OFA on postoperative pain (variation in numeric rating scales) From 0 to 10 => Zero represents "no pain," whereas 10 represents the opposite end of the pain continuum (e.g., "the most intense pain imaginable," "pain as intense as it could be," "maximum pain").
Time Frame
48 hours
Title
Assess the impact of OFA on the consumption of postoperative morphine
Description
To assess the impact of OFA on the consumption of postoperative morphine (consumption in mg)
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Eligible patients for scheduled total hip arthroplasty with general anesthesia. Patients with an American Society of Anesthesiologists (ASA) score between 1 and 3 Patient who has received appropriate information and has provided informed consent. Patient with French social security system. Exclusion Criteria: Patients eligible to rapid sequence intubation. Patients with medical contraindication to the use of OFA : allergy to one of the drug used in the protocol, spontaneous bradycardia under 40bpm or atrioventricular block. Patients with a medical condition that could alter measurement of cardiac index by NICCOMO™: acute pulmonary oedema, severe valvular heart disease, pulmonary hypertension, atrial fibrillation. Patients who cannot give their informed consent. Patients pregnant or breastfeeding. Patients odler than 90 years old or with a weigh superior at 150kg.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edmundo Souza Neto, PhD
Phone
33 7 70 01 72 59
Email
edmundo.pereira-de-souza@hotmail.fr
Facility Information:
Facility Name
Edmundo Pereira de Souza Neto
City
Montauban
State/Province
Tarn Et Garonne
ZIP/Postal Code
82000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edmundo P SOUZA NETO, PhD
Phone
335.63.92.83.36
Email
edmundo.pereira-de-souza@hotmail.fr
First Name & Middle Initial & Last Name & Degree
Marlène P DUBOIS
Phone
33 5 63 92 89 94
Email
m.dubois@ch-montauban.fr
First Name & Middle Initial & Last Name & Degree
Edmundo SOUZA NETO, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18443635
Citation
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Results Reference
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Links:
URL
http://www.transpopmed.org/articles/tppm/tppm-2019-7-104.php
Description
The Benefits of Opioid Free Anesthesia and the Precautions Necessary When Employing It. Transl Perioper Pain Med

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Cardiac Index and General Anesthesia Without Opioid.

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