Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery
NCT ID: NCT05801900
Last Updated: 2023-04-06
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
NA
116 participants
INTERVENTIONAL
2023-04-30
2023-06-30
Brief Summary
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Detailed Description
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Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 2 mcg/kg fentanyl (lean body weight), and tracheal intubation will be facilitated by 0.6 mg/kg ideal body weight rocuronium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg rocuronium every 30 minutes. Fentanyl boluses of 1 mcg/kg will be given if heart rate or/and systolic blood pressure \>120% of baseline.
Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 4, 10, 18, and 24 h after leaving the operating room. If the VAS score is \> 3 intravenous nalbuphine 0.1-0.2 mg/kg (lean body weight) titrated to response with maximum single dose of 20 mg and maximum daily dose of 160 mg.
Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ketorolac group
ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes
Ketorolac group
30 min preoperatively then every 8 hours postoperatively
Ibuprofen group
ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes
Ibuprofen group
30 min preoperatively then every 8 hours postoperatively
Interventions
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Ketorolac group
30 min preoperatively then every 8 hours postoperatively
Ibuprofen group
30 min preoperatively then every 8 hours postoperatively
Eligibility Criteria
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Inclusion Criteria
* body mass index ≥35 kg/m2
* scheduled for laparoscopic bariatric surgery
Exclusion Criteria
* severe cardiac comorbidity (impaired contractility with ejection fraction \< 50%, heart block, significant arrhythmias, tight valvular lesions),
* known obstructive sleep apnea or patients with STOP-bang score ≥5,
* baseline SpO2 \<95%,
* renal impairment,
* allergy to any of study's drugs,
* history of gastrointestinal bleeding or ulceration, or inflammatory bowel disease
18 Years
65 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Hasanin
Principal Investigator
Locations
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Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Other Identifiers
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MS-340-2022
Identifier Type: -
Identifier Source: org_study_id
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