Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery

NCT ID: NCT05801900

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2023-06-30

Brief Summary

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

Detailed Description

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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

Conditions

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Postoperative Pain Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketorolac group

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

Group Type ACTIVE_COMPARATOR

Ketorolac group

Intervention Type DRUG

30 min preoperatively then every 8 hours postoperatively

Ibuprofen group

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

Group Type ACTIVE_COMPARATOR

Ibuprofen group

Intervention Type DRUG

30 min preoperatively then every 8 hours postoperatively

Interventions

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Ketorolac group

30 min preoperatively then every 8 hours postoperatively

Intervention Type DRUG

Ibuprofen group

30 min preoperatively then every 8 hours postoperatively

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Hasanin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Maha Mostafa

Role: CONTACT

01000365115

Other Identifiers

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MS-340-2022

Identifier Type: -

Identifier Source: org_study_id

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