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Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery

Primary Purpose

Postoperative Pain, Bariatric Surgery Candidate

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ketorolac group
Ibuprofen group
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ketorolac group

Ibuprofen group

Arm Description

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

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

Outcomes

Primary Outcome Measures

VAS
Visual analogue scale

Secondary Outcome Measures

total intraoperative fentanyl
mcg
post operative nalbuphine
mg
VAS
Visual analogue scale
time to independent movement
defined as time from extubation to be able independently mobile e.g. using the bathroom

Full Information

First Posted
March 13, 2023
Last Updated
April 5, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05801900
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Bariatric Surgery Candidate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac group
Arm Type
Active Comparator
Arm Description
ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes
Arm Title
Ibuprofen group
Arm Type
Active Comparator
Arm Description
ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes
Intervention Type
Drug
Intervention Name(s)
Ketorolac group
Intervention Description
30 min preoperatively then every 8 hours postoperatively
Intervention Type
Drug
Intervention Name(s)
Ibuprofen group
Intervention Description
30 min preoperatively then every 8 hours postoperatively
Primary Outcome Measure Information:
Title
VAS
Description
Visual analogue scale
Time Frame
30 minutes after extubation
Secondary Outcome Measure Information:
Title
total intraoperative fentanyl
Description
mcg
Time Frame
30 seconds after skin incision until 1 min after skin closure
Title
post operative nalbuphine
Description
mg
Time Frame
30 minutes after extubation until 24 hours postoperatively
Title
VAS
Description
Visual analogue scale
Time Frame
at 0.5, 4, 10, 18, and 24 hours after extubation
Title
time to independent movement
Description
defined as time from extubation to be able independently mobile e.g. using the bathroom
Time Frame
30 minutes after extubation until 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maha Mostafa
Phone
01000365115
Email
maha.mostafa@cu.edu.eg
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
data from this study are available from the PI upon resealable request

Learn more about this trial

Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery

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