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Completed

NCT Number: NCT03124680

Opioid Free Anesthesia and Continuous Post-operative Pulse Oximetry Monitoring in the Obese Patient

Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.

For a long time, opioids have been covering the analgesia function. (1) When using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. Post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known.

Opioid usage is an important risk factor of postoperative desaturation. Postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications.

Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.

Non-opiate protocols implemented on the obese patient have been published. Non-opiate protocols have been established using a combination of ketamine, lidocaine and an alpha-2 agonist.

The main purpose of this pilot study is to evaluate whether patients undergoing an opioid free anaesthesia regime experience less desaturation episodes during the first 24 h post-bariatric surgery than patients having received an opioid anaesthesia regime.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme Hospital

Brussels, 1070, Belgium

About this study

Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.

For a long time, opioids have been covering the analgesia function. When using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. Post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known. These complications may lead to a prolonged hospital stay.

Opioid usage is an important risk factor of postoperative desaturation. Postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications.

Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.

Authors have indeed published non-opiate protocols implemented on the obese patient.

Non-opiate protocols have been established using a combination of ketamine, lidocaine and an alpha-2 agonist.

The main purpose of this pilot study is to evaluate whether patients undergoing an opioid free anaesthesia regime experience less desaturation episodes during the first 24 h post-bariatric surgery than patients having received an opioid anaesthesia regime.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients undergoing a gastric by-pass surgery will be screened.
  • Patients with an ASA physical status of I-II-III (BMI >30) will be included.
  • Knowledge of either French, English or Dutch will be required in order to be enrolled in this study.

Exclusion criteria

  • allergy or contraindications to one of the study drugs
  • renal failure
  • hepatic failure
  • hyperthyroidism
  • AV block 2 or 3
  • severe bradycardia
  • left ventricular failure
  • unstable blood pressure
  • severe respiratory disease
  • epilepsy
  • psychiatric disturbance.

Treatment and study plan

Opioid free

Combination Product

Peroperative opioid free anesthesia will be obtained via a combination of dexmedetomidine, ketamine, lidocaine and magnesium sulfate

Other names: study group

opioid group

Combination Product

Opioid anesthesia will follow the current standard approach of our hospital.

Other names: control group

Primary outcomes

  1. desaturation episode evaluation

    Time frame: first 24 hours postoperative

    The primary outcome of this study is to evaluate desaturation episodes during the first 24 h post-bariatric surgery in patients having received an opioid or an opioid free anaesthesia.

    Desaturation is defined as a decrease of oxygen desaturation equal to or exceeding 4% of the baseline value. ODI (oxygen desaturation index), the total number of desaturation events divided by the total time of monitoring in hours, will be calculated to evaluate this outcome in both groups.

    In case of desaturation lasting longer than 10 seconds, oxygen (via nasal canula) will be administered as per post-anaesthesia care unit protocol.

    SP02 will be measured for 24 hours through non-invasive monitoring.

Sponsors and collaborators

Lead sponsor

Université Libre de Bruxelles

Other

Registry information

Official study title

Opioid Free Anesthesia and Continuous Post-operative Pulse Oximetry Monitoring in the Obese Patient: How About Another Approach?

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 24, 2017
Registry last updated
Jul 19, 2017

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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