Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery

Not Applicable

Not yet recruiting

• Conditions: Bariatric Surgery Candidate; Postoperative Pain
• Interventions: Drug: Ibuprofen group; Drug: Ketorolac group

• Registration Number: NCT05801900
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2023-03-13
• Status Verified: 2023-04
• Study Start: 2023-04
• Study First Submitted QC: 2023-04-05
• Last Update Submitted: 2023-04-05
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen group	Ibuprofen group	ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes
Ketorolac group	Ketorolac group	ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes

Primary Outcome Measures

Name	Time	Method
VAS	30 minutes after extubation	Visual analogue scale

Secondary Outcome Measures

Name	Time	Method
total intraoperative fentanyl	30 seconds after skin incision until 1 min after skin closure	mcg
post operative nalbuphine	30 minutes after extubation until 24 hours postoperatively	mg
VAS	at 0.5, 4, 10, 18, and 24 hours after extubation	Visual analogue scale
time to independent movement	30 minutes after extubation until 24 hours postoperatively	defined as time from extubation to be able independently mobile e.g. using the bathroom

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt