Dexmedetomidine and Ketamine in VATS Surgery

StatusTerminated
PhaseNot applicable
Started

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Record History

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  1. Trial terminated Sponsor's reason: Not enough funding. recruitment less than anticipated Show 5 more changesShow less
    • Lead sponsor: Ciusss de L'Est de l'Île de Montréal to Ciusss de L'Est de l'Île de Montréal
    • Final enrollment: 40 participants (planned 120)
    • Eligibility criteria expanded, about 12 words
    • Study description expanded, about 7 words
    • Site details revised
  2. Primary completion date: Dec 1, 2024 to Dec 1, 2025
    • Study completion date: Jul 1, 2025 to Jul 1, 2026
    v6
  3. Primary completion date: Dec 1, 2023 to Dec 1, 2024
    • Study completion date: Jul 1, 2024 to Jul 1, 2025
    v5
  4. Trial status: Suspended to Recruitingv4 Show 4 more changesShow less
    • Enrollment target: 5 to 120
    • Primary completion date: Dec 1, 2022 to Dec 1, 2023
    • Study completion date: Jul 1, 2023 to Jul 1, 2024
    • Site details revised
  5. Trial status: Recruiting to Suspended Sponsor's reason: recruitment problemsv3 Show 4 more changesShow less
    • Enrollment target: estimated 120 to confirmed 5
    • Primary completion date: Feb 2020 to Dec 1, 2022
    • Study completion date: Jul 2020 to Jul 1, 2023
    • Site details revised
  6. Re-verified, no change to tracked fieldsv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Postoperative pain after VATS surgery is significant and associated with moderate to high post operative morphine requirements, which can cause opioid related side effects and delay postoperative recovery. To reduce this requirement, multimodal analgesia with non opioid medication such as dexmedetomidine and ketamine can be used. These drugs have demonstrated significant opioid-sparing properties after various types of surgeries. However, very little is known about their ability to do so in VATS surgery. Also, their relative opioid-sparing properties have not been compared, and it is not known whether their combined use can lead to an additional opioid-sparing effect. The primary goal of this study will be to determine the impact of a combined intra operative infusion of ketamine and dexmedetomidine on postoperative morphine requirements in patients undergoing elective VATS, compared to both these drugs infused separately. The hypothesis is that this combined infusion will lead to a 30% further reduction in morphine requirements, 24h after surgery, compared to both these drugs infused separately.
Trial Details
NCT Number NCT03596424
Lead Sponsor Ciusss de L'Est de l'Île de Montréal
Conditions
(from sponsor)		 Postoperative Pain, Opioid Use
Related terms Postoperative Pain
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov