Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery

Cairo University (CU)

Status: Not yet enrolling

Conditions: Postoperative Pain; Bariatric Surgery Candidate

Treatments: Drug: Ibuprofen group; Drug: Ketorolac group

Study type: Interventional

Funder types: Other

Identifiers

NCT05801900

MS-340-2022

Details and patient eligibility

About

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

Full 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

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 2 patient groups

Ketorolac group

Active Comparator group

Description:

ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes

Treatment:

Drug: Ketorolac group

Ibuprofen group

Active Comparator group

Description:

ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes

Treatment:

Drug: Ibuprofen group