Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05801900

Collaborator

(none)

116

Enrollment

Location

Arms

Anticipated Duration (Months)

57.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Bariatric Surgery Candidate	Drug: Ketorolac group Drug: Ibuprofen group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control in Morbid Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ketorolac group ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes	Drug: Ketorolac group 30 min preoperatively then every 8 hours postoperatively
Active Comparator: Ibuprofen 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

Arm

Intervention/Treatment

Active Comparator: Ketorolac group

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

Drug: Ketorolac group

30 min preoperatively then every 8 hours postoperatively

Active Comparator: Ibuprofen 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

Outcome Measures

Primary Outcome Measures

VAS [30 minutes after extubation]
Visual analogue scale

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Hasanin, Principal Investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05801900

Other Study ID Numbers:

MS-340-2022

First Posted:

Apr 6, 2023

Last Update Posted:

Apr 6, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Ibuprofen

Ketorolac

Study Results

No Results Posted as of Apr 6, 2023