An interventional study of Ketorolac group and Ibuprofen group in Postoperative Pain and Bariatric Surgery Candidate, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
The aim of the current study is to compare the analgesic effects of both drugs in patients with obesity undergoing bariatric surgery.
Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 5 mg dexamethasone drugs.
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
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 116 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes
Drug: Ketorolac group
ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes
Drug: Ibuprofen group
30 min preoperatively then every 8 hours postoperatively
30 min preoperatively then every 8 hours postoperatively
VAS
Visual analogue scale
Time frame: 30 minutes after extubation
total intraoperative fentanyl
mcg
Time frame: 30 seconds after skin incision until 1 min after skin closure
post operative nalbuphine
mg
Time frame: 30 minutes after extubation until 24 hours postoperatively
VAS
Visual analogue scale
Time frame: at 0.5, 4, 10, 18, and 24 hours after extubation
time to independent movement
defined as time from extubation to be able independently mobile e.g. using the bathroom
Time frame: 30 minutes after extubation until 24 hours postoperatively
Plan to share: No — data from this study are available from the PI upon resealable request
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Cairo University