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Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk

Study acronym: OPTI-TWO
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 18 to 20 Eligibility criteria expanded, about 30 words · Secondary endpoints: details revised at 3 of 14 entries · Collaborators: details revised at 1 of 1 entry Show 3 more changesShow less
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 3 of 14 entries
    • Collaborators: details revised at 1 of 1 entry
  2. Primary completion date: Jan 2027 to Feb 2028 Study sites: 14 to 18 · Completion date: Dec 2027 to Feb 2028 · Eligibility criteria expanded, about 24 wordsv6 Show 3 more changesShow less
    • Study sites: 14 to 18
    • Completion date: Dec 2027 to Feb 2028
    • Eligibility criteria expanded, about 24 words

    See this version in full on ClinicalTrials.gov ↗

  3. 2 versions Re-verified since Nov 14, 2024, no change to tracked fieldsv4-v5
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2023 to Oct 12, 2023 · Site details revised at 14 of 14 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Sep 2023 to Oct 12, 2023
    • Site details revised at 14 of 14 sites
  5. Start date: Jun 1, 2023 to Sep 2023 Primary completion date: Jan 31, 2027 to Jan 2027 · Completion date: Dec 31, 2027 to Dec 2027v2 Show 2 more changesShow less
    • Primary completion date: Jan 31, 2027 to Jan 2027
    • Completion date: Dec 31, 2027 to Dec 2027
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Intraoperative hypotension is a common situation. It increases postoperative morbidity and mortality, especially in patients at high postoperative risk undergoing high-risk surgery. Intraoperative hypotension is partly related to anesthesia, and mainly to the combined, dose-dependent, synergistic effect of hypnotics and opioids. Monitoring sedation and monitoring analgesia reduce intraoperative consumption of each anesthetic agent. To date, the beneficial effect of combined sedation and analgesia monitoring on the reduction of intraoperative hypotension has only been found in one study, involving major abdominal surgery. Up to now, no study has been designed to demonstrate the benefit of monitoring the two components of anesthesia on postoperative organ dysfunction and mortality. The study propose to evaluate the relevance of a combined optimization of hypnotic and opioid agents on the most frequently encountered dysfunctions related to intraoperative hypotension.
Trial Details
NCT Number NCT05893030
Lead Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Direction Générale de l'Offre de Soins
Conditions Sedation and Analgesia Monitoring
Enrollment 1,132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov