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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 November 2022 |
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Main ID: |
NCT03420586 |
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Date of registration:
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19/01/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Nitrous Oxide Added at the End of Sevoflurane Anesthesia and Recovery
SEVONATE |
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Scientific title:
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Effects of Nitrous Oxide Added at the End of Sevoflurane Anesthesia on Recovery and Postoperative Nausea and Vomiting - a Randomized Clinical Trial (SEVONATE) |
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Date of first enrolment:
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February 7, 2018 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03420586 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Boris Mraovic, Prof, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Anesthesiology & Parioperative Medicine School of Medicine, University of Missouri, Columbia, US |
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Name:
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Tatjana Simurina, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GH Zadar, Dpt. of Anesthesiology and Intensive Care Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients, American Society of Anesthesiologists Physical status ASA PS I-III,
scheduled for laparotomic and laparoscopic surgery expected to last 2 hours or more
who can understand and signed informed consent.
Exclusion Criteria:
- Patients who will be discharged within 72 hours after surgery
- Patients on intensive care within few months before the study enrollment
- Diseases that impair gastric motility (diabetes mellitus, chronic cholecystitis,
gastric and intestinal disease, neuromuscular disorders, neuropathies, liver
dysfunction)
- Vestibular disease; history of migraine headaches, central nervous system injury
- Renal impairment
- Patients on antihistamines, antipsychotics, contraceptives, steroids within 72 hours
before surgery
- Known hypersensitivity to drugs used in the study protocol
- Alcoholism, and/or opioid addiction
- Conditions that can influence the incidence of PONV, postoperative pain or morbidity
(e.g., significant intraoperative surgery complications), intraoperative drug allergy,
severe intraoperative hypotension, perioperative hypoxia, excessive blood loss,
difficult intubation
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Elective Surgical Procedures
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Anesthesia, General
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Anesthesia Recovery Period
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Laparoscopy
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Laparotomy
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Intervention(s)
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Drug: Nitrous Oxide
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Primary Outcome(s)
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Early recovery (awakening) in the operation room (OR)
[Time Frame: 15 minutes]
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Secondary Outcome(s)
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Postoperative nausea and vomiting
[Time Frame: 24 hours]
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Quality of recovery
[Time Frame: 72 hours]
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Postoperative pain
[Time Frame: 24 hours]
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Secondary ID(s)
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01-5623-7/17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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