Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery

NCT05801900 | Unknown

• 1 other identifier: MS-340-2022
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• VAS

  Visual analogue scale

  30 minutes after extubation

Secondary Outcomes (4)

• total intraoperative fentanyl

  30 seconds after skin incision until 1 min after skin closure

• post operative nalbuphine

  30 minutes after extubation until 24 hours postoperatively

• VAS

  at 0.5, 4, 10, 18, and 24 hours after extubation

• time to independent movement

  30 minutes after extubation until 24 hours postoperatively

Study Arms (2)

Ketorolac group

ACTIVE COMPARATOR

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

Drug: Ketorolac group

Ibuprofen group

ACTIVE COMPARATOR

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

Drug: Ibuprofen group

Interventions

Ketorolac group DRUG

30 min preoperatively then every 8 hours postoperatively

Ketorolac group

Ibuprofen group DRUG

30 min preoperatively then every 8 hours postoperatively

Ibuprofen group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Maha Mostafa

CONTACT

01000365115; maha.mostafa@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 6, 2023
• Study Start: April 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)