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Completed

NCT Number: NCT05446623

Cardiac Index and General Anesthesia Without Opioid.

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Edmundo Pereira de Souza Neto

Montauban, Tarn et Garonne, 82000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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

Sufentanil

Drug

The one in the OA group will be given a bolus of Sufentanil before and during the surgery.

Other names: Sufenta

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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").

  4. 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Montauban

Other

Registry information

Official study title

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

Acronym: OFFLOW

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2022
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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