Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2016-05-31
2017-08-31
Brief Summary
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Detailed Description
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Anesthesia depth will be measured by Bispectral index (BIS), titration of sevoflurane to a BIS of 45-60. In case of neuromuscular block reversal at the end of surgery, sugammadex will be administered.
At induction, 1 mg IV atropine 0.1% OR 10ml saline will be administered, depending on group allocation, on a syringe prepared by an anaesthesiologist not involved in the study.
Patients will receive ketorolac 30 mg/8h, acetaminophen 1g/8h and a morphine IV patient controlled anaesthesia pump (PCA) 0-1-8 Outcomes will be evaluated at the postoperative care unit (PACU) and 24 postoperative hours by an investigator blinded to study group
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Atropine
Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia
Atropine
IV atropine 0.1%, 10 ml
Sevoflurane
All patients will receive anaesthesia based on sevoflurane, titrated to a bis of 45-60
sugammadex
Patients will receive sugamadex for neuromuscular reversion, if necessary
Ketorolac
60 mg IV ketorolac will be administered at induction, and patients will receive 30mg/8h on the postoperative period
Morphine PCA
Patients will receive a PCA of morphine with a program of 0 (continuous infusion), 1 mg bolus and 8 minutes lockout
rocuronium
general anaesthesia will use rocuronium 0.6 mg/kg to facilitate intubation
propofol
for anaesthesia induction, patients will receive 2-3 mg/kg iv propofol
placebo
Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia
Placebo
IV saline, 10 ml
Sevoflurane
All patients will receive anaesthesia based on sevoflurane, titrated to a bis of 45-60
sugammadex
Patients will receive sugamadex for neuromuscular reversion, if necessary
Ketorolac
60 mg IV ketorolac will be administered at induction, and patients will receive 30mg/8h on the postoperative period
Morphine PCA
Patients will receive a PCA of morphine with a program of 0 (continuous infusion), 1 mg bolus and 8 minutes lockout
rocuronium
general anaesthesia will use rocuronium 0.6 mg/kg to facilitate intubation
propofol
for anaesthesia induction, patients will receive 2-3 mg/kg iv propofol
Interventions
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Atropine
IV atropine 0.1%, 10 ml
Placebo
IV saline, 10 ml
Sevoflurane
All patients will receive anaesthesia based on sevoflurane, titrated to a bis of 45-60
sugammadex
Patients will receive sugamadex for neuromuscular reversion, if necessary
Ketorolac
60 mg IV ketorolac will be administered at induction, and patients will receive 30mg/8h on the postoperative period
Morphine PCA
Patients will receive a PCA of morphine with a program of 0 (continuous infusion), 1 mg bolus and 8 minutes lockout
rocuronium
general anaesthesia will use rocuronium 0.6 mg/kg to facilitate intubation
propofol
for anaesthesia induction, patients will receive 2-3 mg/kg iv propofol
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
FEMALE
No
Sponsors
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Clinica Santa Maria
OTHER
Responsible Party
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David Torres
Principal Investigator
Locations
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Clinica Santa Maria
Santiago, , Chile
Countries
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Other Identifiers
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CSM2016001
Identifier Type: -
Identifier Source: org_study_id
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