Clinical trial NCT05801900: Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery
Official title: Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control in Morbid Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Bariatric Surgery Candidate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to compare the analgesic effects of both drugs in patients with obesity undergoing bariatric surgery.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* adult (18-65 years) patients
* body mass index ≥35 kg/m2
* scheduled for laparoscopic bariatric surgery

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical class IV,
* 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

Primary outcomes:
measure: VAS
timeFrame: 30 minutes after extubation
Secondary outcomes:
measure: total intraoperative fentanyl
timeFrame: 30 seconds after skin incision until 1 min after skin closure
measure: post operative nalbuphine
timeFrame: 30 minutes after extubation until 24 hours postoperatively
measure: VAS
timeFrame: at 0.5, 4, 10, 18, and 24 hours after extubation
measure: time to independent movement
timeFrame: 30 minutes after extubation until 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: