Cardiac Index and General Anesthesia Without Opioid. (OFFLOW)

March 17, 2026 updated by: Centre Hospitalier de Montauban

Comparative Study of General Anesthesia With or Without Opioid on the Cardiac Index During Total Hip Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Tarn et Garonne
      • Montauban, Tarn et Garonne, France, 82000
        • Edmundo Pereira de Souza Neto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Opioid free anesthesia (OFA)
The patients included in the OFA group will receive a bolus of Dexmedetomidine at the beginning of the surgery.
Drug: Dexmedetomidine
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.
Other Names:
  • DEXDOR
Sham Comparator: anesthesia with opioid (OA)
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.
Drug: Sufentanil
The one in the OA group will be given a bolus of Sufentanil before and during the surgery.
Other Names:
  • Sufenta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the impact of opioid free anesthesia on the cardiac index
Time Frame: 60 minutes
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.
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the impact of the OFA in hemodynamical state
Time Frame: 60 minutes
To assess the impact of the OFA protocol on Blood pressure (variation of Blood pressure measured in mmHg)
60 minutes
Assess the impact of the OFA protocol on heart rate
Time Frame: 60 minutes
To assess the impact of the OFA protocol on heart rate (variation in heart rate measured in beats per minute)
60 minutes
Assess the impact of OFA on postoperative pain
Time Frame: 48 hours
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").
48 hours
Assess the impact of OFA on the consumption of postoperative morphine
Time Frame: 48 hours
To assess the impact of OFA on the consumption of postoperative morphine (consumption in mg)
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Montauban

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

October 2, 2024

Study Completion (Actual)

October 2, 2024

Study Registration Dates

First Submitted

June 19, 2022

First Submitted That Met QC Criteria

July 2, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02873-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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