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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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16 December 2017 |
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Main ID: |
NCT03045133 |
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Date of registration:
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03/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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QUALITY OF RECOVERY AFTER INTRAOPERATIVE MORPHINE OR METHADONE
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Scientific title:
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QUALITY OF RECOVERY AFTER INTRAOPERATIVE MORPHINE OR METHADONE IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY |
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Date of first enrolment:
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June 20, 2016 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03045133 |
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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: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Eduardo T Moro, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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PUC São Paulo University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ASA physical status I or II, who will be scheduled to undergo laparoscopic
cholecystectomy at Santa Lucinda Hospital
Exclusion Criteria:
- Patients who (i) refuse to participate in the study; (ii) are not able to communicate
due to alterations in the level of consciousness, or neurologic, or psychiatric
disease; - present with contraindication to any of the drugs used in the present study
- have history of alcohol or drug abuse
- present a body mass index (BMI) = 40 will be excluded.
- Reasons for exclusion after randomization will be protocol violations or if the
surgical procedure changes from a laparoscopic to an open approach.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pain, Postoperative
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Nausea and Vomiting, Postoperative
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Intervention(s)
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Drug: Methadone
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Drug: Morphine
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Primary Outcome(s)
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Quality of recovery (QoR-40)
[Time Frame: 24 hours]
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Secondary Outcome(s)
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Postoperative pain (Ward)
[Time Frame: 24 hours]
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Time of PACU staying
[Time Frame: 3 hours]
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Time to eye opening
[Time Frame: 30 minutes]
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Tramadol consumption
[Time Frame: 24 hours]
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Postoperative nausea and vomiting
[Time Frame: 24 hours]
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Postoperative pain (PACU)
[Time Frame: 2 hours]
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Secondary ID(s)
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PUCSP 050539/2016
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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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